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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug919 | Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument Wiki | 0.71 |
| drug3443 | SARS-CoV-2 rapid diagnostic test (COVID-PRESTO® IgM/IgG, AAZ, Boulogne-Billancourt, France) Wiki | 0.71 |
| drug3252 | Rabeprazole Wiki | 0.50 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000542 | Alveolitis, Extrinsic Allergic NIH | 0.71 |
| D000532 | Altitude Sickness NIH | 0.71 |
| D006967 | Hypersensitivity, NIH | 0.32 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0006516 | Hypersensitivity pneumonitis HPO | 0.71 |
| HP:0012393 | Allergy HPO | 0.32 |
| HP:0006515 | Interstitial pneumonitis HPO | 0.19 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002088 | Abnormal lung morphology HPO | 0.14 |
| HP:0002090 | Pneumonia HPO | 0.04 |
Navigate: Correlations HPO
There are 2 clinical trials
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral dose pharmacokinetic (PK).
Description: An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.
Measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Time: Baseline up to Day 9 for SAD Cohorts; Baseline up to Day 24 for MAD CohortsThe primary objectives of this study are: to evaluate the pharmacokinetic (PK) profiles of BIIB091 modified release (MR) formulations in healthy participants after single dose administration in the fasted state (Part 1); to determine the PK of a single dose of the selected BIIB091 MR formulation in the fed and fasted state in healthy participants (Part 2); to evaluate the PK of the selected BIIB091 MR formulation in healthy participants after multiple dose administration (Part 3). The secondary objectives of this study are: to determine the relative bioavailability of a single dose of the BIIB091 MR formulations compared to that of the immediate release (IR) drug in capsule (DiC) reference formulation in healthy participants in the fasted state, to assess the safety and tolerability of single doses of BIIB091 when administered as MR formulations in healthy participants in the fasted state (Part 1); to assess the safety and tolerability of single dose of BIIB091 when administered as the selected MR formulation in healthy participants in the fed and fasted states, to determine the relative bioavailability of single dose of the selected BIIB091 MR formulation in healthy participants taking a proton pump inhibitor (PPI) compared to healthy participants not taking a PPI, in the fasted state, to determine the relative bioavailability of single dose of the selected BIIB091 MR formulation in healthy participants taking a cytochrome P450 (CYP) 3A4 inhibitor compared to healthy participants not taking a CYP3A4 inhibitor, in the fasted state, to assess the safety and tolerability of single dose of BIIB091 when administered as the selected MR formulation in healthy participants taking a PPI in the fasted state, to assess the safety and tolerability of single dose of BIIB091 when administered as the selected MR formulation in healthy participants taking a CYP3A4 inhibitor in the fasted state (Part 2); to assess the safety and tolerability of multiple doses of BIIB091 when administered as the selected MR formulation in healthy participants (Part 3).
Description: Parameter will be evaluated for the fed versus (vs) fasted comparison in Part 2.
Measure: Parts 1 and 2: Time Prior to the First Measurable Concentration (Tlag) of BIIB091 Time: Parts 1 and 2: Up to Day 4Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Parts 1, 2 and 3: Time of Maximum Observed Concentration (Tmax) of BIIB091 Time: Parts 1 and 2: Up to Day 4; Part 3: Up to Day 13Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Parts 1, 2 and 3: Maximum Observed Concentration (Cmax) of BIIB091 Time: Parts 1 and 2: Up to Day 4; Part 3: Up to Day 13Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Parts 1, 2 and 3: Plasma Concentration at 12 Hours (C12h) of BIIB091 Time: Parts 1 and 2: Up to Day 4; Part 3: Up to Day 13Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Parts 1, 2 and 3: Plasma Concentration at 24 Hours (C24h) of BIIB091 Time: Parts 1 and 2: Up to Day 4; Part 3: Up to Day 13Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Parts 1, 2 and 3: Area Under the Curve from Time 0 to 12 Hours Post-Dose [AUC(0-12h)] of BIIB091 Time: Parts 1 and 2: Up to Day 4; Part 3: Up to Day 13Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Parts 1 and 2: Area Under the Curve from Time 0 to 24 Hours Post-Dose [AUC(0-24h)] of BIIB091 Time: Parts 1 and 2: Up to Day 4Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Parts 1 and 2: Area Under the Curve from Time 0 to the Time of Last Measurable Concentration [AUC(0-last)] of BIIB091 Time: Parts 1 and 2: Up to Day 4Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Parts 1, 2 and 3: Area Under the Curve from Time 0 Extrapolated to Infinity [AUC(0-inf)] of BIIB091 Time: Parts 1 and 2: Up to Day 4; Part 3: Up to Day 13Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Parts 1 and 2: Area Under the Curve from Time of the Last Measurable Concentration to Infinity as a Percentage of the Area Under the Curve Extrapolated to Infinity (AUC%extrap) of BIIB091 Time: Parts 1 and 2: Up to Day 4Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Parts 1, 2 and 3: Terminal Elimination Half-Life (T1/2) of BIIB091 Time: Parts 1 and 2: Up to Day 4; Part 3: Up to Day 13Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Parts 1, 2 and 3: First Order Rate Constant Associated with the Terminal (Log-Linear) Portion of the Curve (Lambda-z) of BIIB091 Time: Parts 1 and 2: Up to Day 4; Part 3: Up to Day 13Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Parts 1 and 2: Total Body Clearance of BIIB091 Calculated After a Single Extravascular Administration Where Fraction of Dose Bioavailable (F) is Unknown (CL/F) Time: Parts 1 and 2: Up to Day 4Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Parts 1 and 2: Apparent Volume of Distribution of BIIB091 Based on the Terminal Phase Calculated Using AUC(0-inf) After a Single Extravascular Administration Where F is Unknown (Vd/F) Time: Parts 1 and 2: Up to Day 4Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Part 2: Relative Bioavailability of BIIB091 Based on Cmax (Frel Cmax) Time: Part 2: Up to Day 4Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Part 2: Relative Bioavailability of BIIB091 Based on AUC(0-last) [Frel AUC(0-last)] Time: Part 2: Up to Day 4Description: Parameter will be evaluated for the fed vs fasted comparison in Part 2.
Measure: Part 2: Relative Bioavailability of BIIB091 Based on AUC(0-inf) [Frel AUC(0-inf)] Time: Part 2: Up to Day 4Description: The formula used will be (Cmax-Cmin)/average concentration (Cavg) × 100
Measure: Part 3: Peak to Trough Fluctuation Time: Part 3: Up to Day 13Description: An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
Measure: Parts 1, 2 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Time: From Signing of Informed Consent Form (ICF) Until Follow-up Phone Call (Part 1: Up to 15 weeks; Part 2: Up to 9 weeks; Part 3: Up to 7 weeks)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports