Covid 19 Research using Clinical Trials (Home Page)
Report for D002658: Developmental Disabilities NIH
(Synonyms: Developmenta, Developmental Disabilities)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1708 | Other drugs Wiki | 1.00 |
| drug2004 | RO6953958 Wiki | 1.00 |
| drug1592 | Niclosamide Wiki | 0.71 |
| drug560 | Chloroquine Wiki | 0.35 |
| drug1598 | Nitazoxanide Wiki | 0.35 |
| drug923 | Favipiravir Wiki | 0.24 |
| drug1270 | Ivermectin Wiki | 0.24 |
| drug1822 | Placebo Wiki | 0.06 |
Correlated MeSH Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D065886 | Neurodevelopmental Disorders NIH | 0.71 |
| D002659 | Child Development Disorders, Pervasive NIH | 0.58 |
| D001321 | Autistic Disorder NIH | 0.50 |
| D000067877 | Autism Spectrum Disorder NIH | 0.41 |
| D001523 | Mental Disorders NIH | 0.21 |
| D004194 | Disease NIH | 0.18 |
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000717 | Autism HPO | 0.50 |
| HP:0000729 | Autistic behavior HPO | 0.41 |
There is one clinical trial.
Clinical Trials
1 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
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