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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2111 | Lazertinib Wiki | 0.58 |
| drug919 | Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument Wiki | 0.58 |
| drug142 | ASTX660 Wiki | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000542 | Alveolitis, Extrinsic Allergic NIH | 0.58 |
| D006967 | Hypersensitivity, NIH | 0.26 |
| D011665 | Pulmonary Valve Insufficiency NIH | 0.19 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D017563 | Lung Diseases, Interstitial NIH | 0.15 |
| D008171 | Lung Diseases, NIH | 0.12 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.05 |
| D055371 | Acute Lung Injury NIH | 0.05 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.04 |
| D011014 | Pneumonia NIH | 0.03 |
| D018352 | Coronavirus Infections NIH | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0006516 | Hypersensitivity pneumonitis HPO | 0.58 |
| HP:0012393 | Allergy HPO | 0.26 |
| HP:0010444 | Pulmonary insufficiency HPO | 0.19 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0006515 | Interstitial pneumonitis HPO | 0.15 |
| HP:0002088 | Abnormal lung morphology HPO | 0.12 |
| HP:0002090 | Pneumonia HPO | 0.03 |
Navigate: Correlations HPO
There are 3 clinical trials
The purpose of this study is to evaluate the effects of multiple doses of strong cytochrome P450 (CYP) 3A4 inhibitor itraconazole and strong CYP3A4 inducer rifampin on the single dose pharmacokinetics (PK) of lazertinib in healthy adult participants.
Description: Cmax is defined as maximum plasma concentration.
Measure: Cohort 1 and 2: Maximum Plasma Concentration (Cmax) of Lazertinib Time: Predose up to 120 hours post doseDescription: AUC (0-120h) is defined as area under the plasma concentration-time curve from time 0 to 120 hours postdose.
Measure: Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time 0 to 120 Hours (AUC [0-120h]) of Lazertinib Time: Predose up to 120 hours post doseDescription: AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable timepoint.
Measure: Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Timepoint (AUC [0-last]) of Lazertinib Time: Predose up to 120 hours post doseDescription: AUC (0-inf) is defined as area under the plasma concentration-time curve from time 0 to infinity, calculated as the sum of AUC(0-last)+C(last)/ lambda(z), where C(last) is the last observed measurable (non-below limit of quantification) concentration.
Measure: Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of Lazertinib Time: Predose up to 120 hours post doseDescription: %AUC (0-inf),ex is defined as percentage of area under the plasma concentration from time zero to infinite time obtained by extrapolation, calculated as (AUC [0-infinity] minus AUC [0-last]/AUC [0-infinity])*100.
Measure: Cohort 1 and 2: Percentage of Area Under the Plasma Concentration from time Zero to Infinite time obtained by Extrapolation (%AUC [0-inf],ex) of Lazertinib Time: Predose up to 120 hours post doseDescription: An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
Measure: Cohort 1 and Cohort 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability Time: Up to 65 days (Cohort 1) and up to 70 days (Cohort 2)In Part 1, the primary objective is to investigate the effect of multiple doses of itraconazole, an inhibitor of CYP3A4, on the pharmacokinetic (PK) profile of a single dose of ASTX660. In Part 2, the primary objective is to investigate the effect of a single dose of ASTX660 on the pharmacokinetics of the CYP3A4 substrate midazolam and its metabolite, 1-hydroxy midazolam. Safety and tolerability of a single dose of ASTX660 in the absence and presence of multiple doses of the CYP3A4 inhibitor itraconazole and in the presence of a single dose of the CYP3A4 substrate midazolam will also be evaluated.
Description: Maximum plasma concentration
Measure: Pharmacokinetic parameter of ASTX660: Cmax Time: From predose up to Day 14Description: Area under the plasma concentration versus time curve from time zero to the last measurable concentration
Measure: Pharmacokinetic parameter of ASTX660: AUC0-t Time: From predose up to Day 14Description: Area under the plasma concentration versus time curve from time zero to 24 hours
Measure: Pharmacokinetic parameter of ASTX660: AUC0-24 Time: From predose up to Day 14Description: Area under the plasma concentration versus time curve from time zero extrapolated to infinity
Measure: Pharmacokinetic parameter of ASTX660: AUC0-inf Time: From predose up to Day 14Description: Maximum plasma concentration
Measure: Pharmacokinetic parameter of midazolam and 1-hydroxyl midazolam: Cmax Time: From predose up to Day 9Description: Area under the plasma concentration versus time curve from time zero to the last measurable concentration
Measure: Pharmacokinetic parameter of midazolam and 1-hydroxyl midazolam: AUC0-t Time: From predose up to Day 9Description: Area under the plasma concentration versus time curve from time zero to 24 hours
Measure: Pharmacokinetic parameter of midazolam and 1-hydroxyl midazolam: AUC0-24 Time: From predose up to Day 9Description: Area under the plasma concentration versus time curve from time zero extrapolated to infinity
Measure: Pharmacokinetic parameter of midazolam and 1-hydroxyl midazolam: AUC0-inf Time: From predose up to Day 9Description: Total apparent clearance
Measure: Pharmacokinetic parameter for ASTX660: CL/F Time: From predose up to Day 14Description: Observed terminal half-life
Measure: Pharmacokinetic parameter for ASTX660: t1/2 Time: From predose up to Day 14Description: Total apparent clearance
Measure: Pharmacokinetic parameter for midazolam: CL/F Time: From predose up to Day 9Description: Observed terminal half-life
Measure: Pharmacokinetic parameter for midazolam: t1/2 Time: From predose up to Day 9The 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