Covid 19 Research using Clinical Trials (Home Page)
Report for D065886: Neurodevelopmental Disorders NIH
(Synonyms: Neurodevelopmental Disorders)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2344 | RO6953958 Wiki | 0.71 |
| drug618 | Caring Contacts Wiki | 0.71 |
| drug2055 | Parents and Infants Engaged Wiki | 0.71 |
| drug2031 | PLACEBO Wiki | 0.50 |
| drug610 | Cannabidiol Wiki | 0.50 |
| drug2122 | Placebo Wiki | 0.04 |
Correlated MeSH Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D002658 | Developmental Disabilities NIH | 0.71 |
| D000067877 | Autism Spectrum Disorder NIH | 0.47 |
| D002659 | Child Development Disorders, Pervasive NIH | 0.41 |
| D001321 | Autistic Disorder NIH | 0.27 |
| D004194 | Disease NIH | 0.24 |
| D001523 | Mental Disorders NIH | 0.14 |
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000729 | Autistic behavior HPO | 0.47 |
| HP:0000717 | Autism HPO | 0.27 |
There are 2 clinical trials
Clinical Trials
1 Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders
This study entails a "proof of concept" evaluation of a novel intervention, Parents and Infants Engaged (PIE), for prodromal infants at-risk for neurodevelopmental disorders (NDs). The objectives of the current study are to examine whether the PIE intervention (a) transforms parent-infant transactions over time as intended, thereby facilitating increases in the time infants spend in joint engagement with their parents, and (b) is associated with improved social-communication functioning and positive changes in indices of autonomic self-regulation in infants at-risk for NDs.
NCT03388294 Autism Spectrum Disorder Neurodevelopmental Disorders Behavioral: Parents and Infants Engaged MeSH:Disease Autism Spectrum Disorder Neurodevelopmental Disorders
HPO:Autistic behavior
Primary Outcomes
Description: This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in joint engagement (supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent studies with children with NDs have shown that the coding system is sensitive to change in joint engagement after relatively short interventions.
Measure: Change in Parent Child Engagement Coding from pretest to posttest 1 Time: Baseline, posttest 1 (6-8 weeks after pretest)
Description: This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in joint engagement (supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent studies with children with NDs have shown that the coding system is sensitive to change in joint engagement after relatively short interventions.
Measure: Change in Parent Child Engagement Coding from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)
Secondary Outcomes
Description: The MSEL is a standardized developmental assessment for children birth to 58 months, frequently used in studies of children with NDs, and comprised of 4 scales: Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The investigators will administer only the Receptive and Expressive Language subscales of the MSEL at the second posttest and the first follow up assessment. To be eligible for the intervention portion of the study, children have to score at least 1 s.d. below the mean on either the Receptive or Expressive Language subscale of the MSEL. The investigators will report t scores (Mean = 50, SD = 10)and the standardized total Early Learning Composite (Mean = 100, SD = 15). Higher scores indicate greater developmental skills.
Measure: Change in Mullen Scales of Early Learning Receptive Language T-Scores from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)
Description: The MSEL is a standardized developmental assessment for children birth to 58 months, frequently used in studies of children with NDs, and comprised of 4 scales: Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The investigators will administer only the Receptive and Expressive Language subscales of the MSEL at the second posttest and the first follow up assessment. To be eligible for the intervention portion of the study, children have to score at least 1 s.d. below the mean on either the Receptive or Expressive Language subscale of the MSEL. The investigators will report t scores (Mean = 50, SD = 10)and the standardized total Early Learning Composite (Mean = 100, SD = 15). Higher scores indicate greater developmental skills.
Measure: Change in Mullen Scales of Early Learning Expressive Language T-scores from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)
Description: A play-based assessment used to measure children's approach-avoidance to novel sensory toys (i.e., hyper-reactivity) and orienting responses (i.e., hypo-reactivity) across three sensory modalities (auditory, visual, tactile). The investigators will report a mean score for Hypo (range = 1-5), Hyper (range = 1-5) sensory subscales. Higher scores indicate greater sensory differences in that domain (e.g. a high hypo domain score would indicate more hyposensitive reactions to sensory stimuli seen in the child).
Measure: Change in Sensory Processing Assessment for Young Children from Pretest to Posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)
Description: A treatment response measure of social communication behaviors and other behaviors associated with autism spectrum disorder (ASD). Administration of the BOSCC involves a 12-minute video recorded interaction between an examiner and a young child using two standard sets of toys and play with bubbles. Behaviors are coded from video. Total score range is 16-80. Higher scores indicate more typical social communication skills, lower scores indicate poorer skills.
Measure: Change in The Behavioral Observation of Social Communication Change (BOSCC) from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)
Description: Designed to measure the extent to which children will follow attentional cues of the examiner. Six prompts for attention following are embedded into the larger study protocol. Items are scored dichotomously as yes "1" or no "0".Total score range is 0-6. Higher scores indicate more typical responses to bids for joint attention.
Measure: Change in The Attention Following Protocol (AF Protocol) from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)
Description: A parent report measure of children's expressive communication skills, such as vocabulary and pre-grammar abilities. The Words and Gestures (toddler) form will be used. Total words and gestures endorsed by parents will be reported. Greater words and gestures reported indicates larger expressive vocabulary.
Measure: Baseline expressive communication level: The MacArthur-Bates Communicative Development Inventory Time: Baseline
Description: A 43 item parent questionnaire that asks about the child's responses to various sensory stimuli in the context of functional activities and daily routines in the child's environment. It also documents strategies parents use to respond to their child's behaviors. Hyper and Hypo mean domain scores will be reported (range = 1-5). Greater domain scores indicate a greater presence of that type of sensory response.
Measure: Change in The Sensory Experiences Questionnaire version 2.1 from pretest to posttest 1 Time: Baseline, posttest 1 (6-8 weeks after pretest)
Description: A 43 item parent questionnaire that asks about the child's responses to various sensory stimuli in the context of functional activities and daily routines in the child's environment. It also documents strategies parents use to respond to their child's behaviors. Hyper and Hypo mean domain scores will be reported (range = 1-5). Greater domain scores indicate a greater presence of that type of sensory response.
Measure: Change in The Sensory Experiences Questionnaire version 2.1 from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)
Description: The Parental Stress Scale is a brief, 18-item scale designed to assess parent stress in nonclinical or clinical populations. It has acceptable levels of internal consistency (coefficient α = .83) and test-retest reliability (r = .81 over 6 weeks). It has good concurrent validity with the widely used Parent StressIndex (r =.75), which is a longer, more intrusive measure. A total score will be reported (range = 18-90).
Measure: Baseline level of parent stress: Parental Stress Scale Time: Baseline
Description: RSA levels will be collected using a standard protocol while the child is seated in a high chair exposed to social and non-social stimuli.
Measure: Change in Respiratory sinus arrhythmia from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)
Description: Skin conductance levels will be collected using a standard protocol while the child is seated in a high chair exposed to social and non-social stimuli.
Measure: Change in skin conductance levels from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)
Description: Parent-child interaction videos will be coded for parent responsiveness to child prelinguistic communication cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Measure: Change in Parent Responsiveness to Child Prelinguistic Communication Cues from pretest to posttest 1 Time: Baseline, posttest 1 (6-8 weeks after pretest)
Description: Parent-child interaction videos will be coded for parent responsiveness to child prelinguistic communication cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Measure: Change in Parent Responsiveness to Child Prelinguistic Communication Cues from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)
Description: Parent-child interaction videos will be coded for parent responsiveness to child sensory reactivity cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Measure: Change in Parent Responsiveness to Child Sensory Reactivity Cues from pretest to posttest 1 Time: Baseline, posttest 1 (6-8 weeks after pretest)
Description: Parent-child interaction videos will be coded for parent responsiveness to child sensory reactivity cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Measure: Change in Parent Responsiveness to Child Sensory Reactivity Cues from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)
2 A Randomized, Investigator- /Subject-blind, Single- and Multiple-ascending Dose, Placebo-controlled Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 Following Oral Administration in Healthy Male Participants
Primary Outcomes
Description: This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in joint engagement (supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent studies with children with NDs have shown that the coding system is sensitive to change in joint engagement after relatively short interventions.
Measure: Change in Parent Child Engagement Coding from pretest to posttest 1 Time: Baseline, posttest 1 (6-8 weeks after pretest)Description: This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in joint engagement (supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent studies with children with NDs have shown that the coding system is sensitive to change in joint engagement after relatively short interventions.
Measure: Change in Parent Child Engagement Coding from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Secondary Outcomes
Description: The MSEL is a standardized developmental assessment for children birth to 58 months, frequently used in studies of children with NDs, and comprised of 4 scales: Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The investigators will administer only the Receptive and Expressive Language subscales of the MSEL at the second posttest and the first follow up assessment. To be eligible for the intervention portion of the study, children have to score at least 1 s.d. below the mean on either the Receptive or Expressive Language subscale of the MSEL. The investigators will report t scores (Mean = 50, SD = 10)and the standardized total Early Learning Composite (Mean = 100, SD = 15). Higher scores indicate greater developmental skills.
Measure: Change in Mullen Scales of Early Learning Receptive Language T-Scores from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: The MSEL is a standardized developmental assessment for children birth to 58 months, frequently used in studies of children with NDs, and comprised of 4 scales: Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The investigators will administer only the Receptive and Expressive Language subscales of the MSEL at the second posttest and the first follow up assessment. To be eligible for the intervention portion of the study, children have to score at least 1 s.d. below the mean on either the Receptive or Expressive Language subscale of the MSEL. The investigators will report t scores (Mean = 50, SD = 10)and the standardized total Early Learning Composite (Mean = 100, SD = 15). Higher scores indicate greater developmental skills.
Measure: Change in Mullen Scales of Early Learning Expressive Language T-scores from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: A play-based assessment used to measure children's approach-avoidance to novel sensory toys (i.e., hyper-reactivity) and orienting responses (i.e., hypo-reactivity) across three sensory modalities (auditory, visual, tactile). The investigators will report a mean score for Hypo (range = 1-5), Hyper (range = 1-5) sensory subscales. Higher scores indicate greater sensory differences in that domain (e.g. a high hypo domain score would indicate more hyposensitive reactions to sensory stimuli seen in the child).
Measure: Change in Sensory Processing Assessment for Young Children from Pretest to Posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: A treatment response measure of social communication behaviors and other behaviors associated with autism spectrum disorder (ASD). Administration of the BOSCC involves a 12-minute video recorded interaction between an examiner and a young child using two standard sets of toys and play with bubbles. Behaviors are coded from video. Total score range is 16-80. Higher scores indicate more typical social communication skills, lower scores indicate poorer skills.
Measure: Change in The Behavioral Observation of Social Communication Change (BOSCC) from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: Designed to measure the extent to which children will follow attentional cues of the examiner. Six prompts for attention following are embedded into the larger study protocol. Items are scored dichotomously as yes "1" or no "0".Total score range is 0-6. Higher scores indicate more typical responses to bids for joint attention.
Measure: Change in The Attention Following Protocol (AF Protocol) from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: A parent report measure of children's expressive communication skills, such as vocabulary and pre-grammar abilities. The Words and Gestures (toddler) form will be used. Total words and gestures endorsed by parents will be reported. Greater words and gestures reported indicates larger expressive vocabulary.
Measure: Baseline expressive communication level: The MacArthur-Bates Communicative Development Inventory Time: BaselineDescription: A 43 item parent questionnaire that asks about the child's responses to various sensory stimuli in the context of functional activities and daily routines in the child's environment. It also documents strategies parents use to respond to their child's behaviors. Hyper and Hypo mean domain scores will be reported (range = 1-5). Greater domain scores indicate a greater presence of that type of sensory response.
Measure: Change in The Sensory Experiences Questionnaire version 2.1 from pretest to posttest 1 Time: Baseline, posttest 1 (6-8 weeks after pretest)Description: A 43 item parent questionnaire that asks about the child's responses to various sensory stimuli in the context of functional activities and daily routines in the child's environment. It also documents strategies parents use to respond to their child's behaviors. Hyper and Hypo mean domain scores will be reported (range = 1-5). Greater domain scores indicate a greater presence of that type of sensory response.
Measure: Change in The Sensory Experiences Questionnaire version 2.1 from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: The Parental Stress Scale is a brief, 18-item scale designed to assess parent stress in nonclinical or clinical populations. It has acceptable levels of internal consistency (coefficient α = .83) and test-retest reliability (r = .81 over 6 weeks). It has good concurrent validity with the widely used Parent StressIndex (r =.75), which is a longer, more intrusive measure. A total score will be reported (range = 18-90).
Measure: Baseline level of parent stress: Parental Stress Scale Time: BaselineDescription: RSA levels will be collected using a standard protocol while the child is seated in a high chair exposed to social and non-social stimuli.
Measure: Change in Respiratory sinus arrhythmia from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: Skin conductance levels will be collected using a standard protocol while the child is seated in a high chair exposed to social and non-social stimuli.
Measure: Change in skin conductance levels from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: Parent-child interaction videos will be coded for parent responsiveness to child prelinguistic communication cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Measure: Change in Parent Responsiveness to Child Prelinguistic Communication Cues from pretest to posttest 1 Time: Baseline, posttest 1 (6-8 weeks after pretest)Description: Parent-child interaction videos will be coded for parent responsiveness to child prelinguistic communication cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Measure: Change in Parent Responsiveness to Child Prelinguistic Communication Cues from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)Description: Parent-child interaction videos will be coded for parent responsiveness to child sensory reactivity cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Measure: Change in Parent Responsiveness to Child Sensory Reactivity Cues from pretest to posttest 1 Time: Baseline, posttest 1 (6-8 weeks after pretest)Description: Parent-child interaction videos will be coded for parent responsiveness to child sensory reactivity cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Measure: Change in Parent Responsiveness to Child Sensory Reactivity Cues from pretest to posttest 2 Time: Baseline, posttest 2 (13-16 weeks after pretest)This study will evaulate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD and MAD) and food effect (FE) of RO6953958 following oral administration in healthy male participants.
NCT04475848 Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Drug: RO6953958 Drug: Placebo MeSH:Disease Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Autistic Disorder Neurodevelopmental Disorders Developmental Disabilities
HPO:Autism Autistic behavior
Primary Outcomes
Measure: Percentage of Participants with Adverse Events in Part 1 Time: From randomization up to 7 weeks (or up to 14 weeks if the participant is part of the food effect cohort)
Measure: Percentage of Participants with Adverse Events in Part 2 Time: From randomization up to 8 weeks
Measure: Part 2: Change in suicide risk assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) Time: From randomization up to 8 weeks
Secondary Outcomes
Measure: Part 1: Maximum Observed Plasma Concentration (Cmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1
Measure: Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1
Measure: Part 1: Last Quantifiable Concentration (Clast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Time To the Last Quantifiable Concentration (Tlast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Terminal Elimination Phase Half-Life (T1/2) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Area Under the Concentration-Time Curve from Time 0 to 12 hours (AUC(0-12h)) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Area Under the Concentration-Time Curve from Time Extrapolated to Infinity (AUC (0-inf)) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Apparent Clearance (CL/F) of RO6953958 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Apparent Volume of Distribution (V/F) of RO6953958 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Cumulative Amount of Unchanged Drug Excreted into the Urine (Ae) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Fraction of the Administered Drug Excreted into the Urine (Fe) of RO6953958 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Renal Clearance of the Drug from Urine (CLR) of RO6953958 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Parts 2: Cmax of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 and Day 10
Measure: Parts 2: Molecular Weight Adjusted Metabolite-to-Parent Ratio for Cmax of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 and Day 10
Measure: Parts 2: Average Plasma Concentration (Cavg) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: Tmax of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 and Day 10
Measure: Part 2: Area Under the Concentration-Time Curve (AUC(0-t)) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: Molecular Weight Adjusted Metabolite-to-Parent Ratio for Area Under the Concentration-Time Curve (AUC(0-t)) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: T1/2 of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: CL/F of RO6953958 Time: Day 1 to Day 14
Measure: Part 2: V/F of RO6953958 Time: Day 1 to Day 14
Measure: Part 2: Ae of RO6953958 Time: Day 1 to Day 14
Measure: Part 2: Fe of RO6953958 Time: Day 1 to Day 14
Measure: Part 2: CLR of RO6953958 Time: Day 1 to Day 14
Measure: Part 2: Trough Plasma Concentration (Ctrough) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: Accumulation Ratio based on AUC (Rauc) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: Accumulation Ratio Based on Cmax (RCmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: Accumulation Ratio based on Ctrough (RCtrough) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
HPO Nodes
Primary Outcomes
Measure: Percentage of Participants with Adverse Events in Part 1 Time: From randomization up to 7 weeks (or up to 14 weeks if the participant is part of the food effect cohort)Measure: Percentage of Participants with Adverse Events in Part 2 Time: From randomization up to 8 weeks
Measure: Part 2: Change in suicide risk assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) Time: From randomization up to 8 weeks
Secondary Outcomes
Measure: Part 1: Maximum Observed Plasma Concentration (Cmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1Measure: Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1
Measure: Part 1: Last Quantifiable Concentration (Clast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Time To the Last Quantifiable Concentration (Tlast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Terminal Elimination Phase Half-Life (T1/2) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Area Under the Concentration-Time Curve from Time 0 to 12 hours (AUC(0-12h)) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Area Under the Concentration-Time Curve from Time Extrapolated to Infinity (AUC (0-inf)) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Apparent Clearance (CL/F) of RO6953958 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Apparent Volume of Distribution (V/F) of RO6953958 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Cumulative Amount of Unchanged Drug Excreted into the Urine (Ae) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Fraction of the Administered Drug Excreted into the Urine (Fe) of RO6953958 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Part 1: Renal Clearance of the Drug from Urine (CLR) of RO6953958 in Fasted and Fed state Time: Day 1 to Day 5
Measure: Parts 2: Cmax of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 and Day 10
Measure: Parts 2: Molecular Weight Adjusted Metabolite-to-Parent Ratio for Cmax of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 and Day 10
Measure: Parts 2: Average Plasma Concentration (Cavg) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: Tmax of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 and Day 10
Measure: Part 2: Area Under the Concentration-Time Curve (AUC(0-t)) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: Molecular Weight Adjusted Metabolite-to-Parent Ratio for Area Under the Concentration-Time Curve (AUC(0-t)) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: T1/2 of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: CL/F of RO6953958 Time: Day 1 to Day 14
Measure: Part 2: V/F of RO6953958 Time: Day 1 to Day 14
Measure: Part 2: Ae of RO6953958 Time: Day 1 to Day 14
Measure: Part 2: Fe of RO6953958 Time: Day 1 to Day 14
Measure: Part 2: CLR of RO6953958 Time: Day 1 to Day 14
Measure: Part 2: Trough Plasma Concentration (Ctrough) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: Accumulation Ratio based on AUC (Rauc) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: Accumulation Ratio Based on Cmax (RCmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14
Measure: Part 2: Accumulation Ratio based on Ctrough (RCtrough) of RO6953958 and its Metabolites RO7021594 and RO7045755 Time: Day 1 to Day 14