Healthy Volunteers
Conditions
Keywords
Drug-Drug Interactions, Pharmacokinetics, Transporter Probe Substrates, CYP P450 Probe Substrates
Brief summary
The purpose of the study if to evaluate the effect of Repotrectinib on the drug levels of transporter and CYP P450 probe substrates in healthy adult participants.
Interventions
DRUGRepotrectinib
Specified dose on specified days
DRUGMetformin
Specified dose on specified days
DRUGDigoxin
Specified dose on specified days
DRUGRosuvastatin
Specified dose on specified days
DRUGBupropion
Specified dose on specified days
DRUGFlurbiprofen
Specified dose on specified days
DRUGOmeprazole
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must have a body mass index (BMI) of 18.0 to 32.0 kg/m2 and should be between the ages of 18-60 years inclusive. * Healthy female (as assigned at birth) participants who are individuals not of childbearing potential (INOCBP) and healthy males with no clinically significant deviation from normal for the following: medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessment results as determined by the investigator.
Exclusion criteria
* Participants must not have a significant history of clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, psychiatric, neoplastic, or genitourinary abnormalities/diseases as determined by the investigator or designee. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration of AUC (0-T) of Probe Substrate With Repotrectinib | Up to approximately Day 17 post dose | Probe substrate contains metformin, digoxin, and rosuvastatin. |
| Cohort 1: AUC (0-T) of Probe Substrate Without Repotrectinib | Up to approximately Day 17 post dose | Probe substrate contains metformin, digoxin, and rosuvastatin. |
| Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Probe Substrate With Repotrectinib | Up to approximately Day 17 post dose | Probe substrate contains metformin, digoxin, and rosuvastatin. |
| Cohort 1: AUC(INF) of Probe Substrate Without Repotrectinib | Up to approximately Day 17 post dose | Probe substrate contains metformin, digoxin, and rosuvastatin. |
| Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Probe Substrate With Repotrectinib | Up to approximately Day 17 post dose | Probe substrate contains metformin, digoxin, and rosuvastatin |
| Cohort 1: Cmax of Probe Substrate Without Repotrectinib | Up to approximately Day 17 post dose | Probe substrate contains metformin, digoxin, and rosuvastatin |
| Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to 48 Hours Post Dose (AUC (0-48)) of Metformin With Repotrectinib | Up to approximately Day 17 post dose | — |
| Cohort 1: AUC (0-48) of Metformin Without Repotrectinib | Up to approximately Day 17 post dose | — |
| Cohort 1: Renal Clearance (CLR) of Metformin in Urine | Up to approximately Day 16 post dose | — |
| Cohort 2: AUC (0-T) of Probe Substrate With Repotrectinib | Up to approximately Day 17 post dose | Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole) |
| Cohort 2: AUC (0-T) of Probe Substrate Without Repotrectinib | Up to approximately Day 17 post dose | Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole) |
| Cohort 2: AUC (INF) of Probe Substrate With Repotrectinib | Up to approximately Day 17 post dose | Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole) |
| Cohort 2: AUC (INF) of Probe Substrate Without Repotrectinib | Up to approximately Day 17 post dose | Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole) |
| Cohort 2: Cmax of Probe Substrate With Repotrectinib | Up to approximately Day 17 post dose | Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole) |
| Cohort 2: Cmax of Probe Substrate Without Repotrectinib | Up to approximately Day 17 post dose | Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole) |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (AEs) | Up to approximately Day 45 post dose |
| Number of Participants with Serious Adverse Events (SAEs) | Up to approximately Day 45 post dose |
| Number of Participants With Clinically Significant Physical Examination Findings | Up to approximately Day 17 post dose |
| Number of Participants With Clinically Significant Vital Sign Measurements | Up to approximately Day 17 post dose |
| Number of Participants With Clinically Significant 12-lead Electrocardiogram (12-lead ECG) Findings | Up to approximately Day 17 post dose |
| Number of Participants With Clinically Significant Safety Laboratory Test Results | Up to approximately Day 17 post dose |
Countries
United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed