Healthy Volunteers
Conditions
Keywords
drug interaction, healthy, repotrectinib, BMS-986472, pharmacokinetics
Brief summary
The purpose of this study is to evaluate the effects of coadministration of voriconazole or quinidine on the pharmacokinetics (PK) of repotrectinib in healthy male and female (individual not of childbearing potential \[INOCBP\]) participants.
Interventions
DRUGRepotrectinib
Specified dose on specified days
DRUGVoriconazole
Specified dose on specified days
DRUGQuinidine
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female individual(s) not of childbearing potential (INOCBP) participants of any race or ethnicity, as determined by no clinically significant findings in medical history, physical examination, 12-lead ECG, or vital signs as determined by the investigator or designee. * Potassium, magnesium, and calcium at or above the lower limit of normal. For other clinical laboratory parameters, no clinically significant findings as determined by the investigator or designee. * Must have a body mass index between 18 and 30 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF.
Exclusion criteria
* History of clinically significant acute or chronic medical illness, such as endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, neoplastic, or genitourinary abnormalities/diseases as determined by the investigator or designee. * History of GI disease or surgery that could possibly affect drug absorption, distribution, metabolism, and excretion (ADME) (eg, bariatric procedure, cholecystectomy). Uncomplicated appendectomy and hernia repair are acceptable. * Gilbert's syndrome. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 23 |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Day 23 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 23 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with Adverse Events (AEs) | Up to Day 52 |
| Number of participants with Severe Adverse Events (SAEs) | Up to Day 52 |
| Number of participants with physical examination abnormalities | Up to Day 23 |
| Number of participants with vital sign abnormalities | Up to Day 23 |
| Number of participants with electrocardiogram abnormalities | Up to Day 23 |
| Number of participants with clinical safety laboratory test abnormalities | Up to Day 22 |
| Time of maximum observed plasma concentration (Tmax) | Up to Day 23 |
| Apparent terminal phase half-life (T-HALF) | Up to Day 23 |
| Apparent total body clearance (CLT/F) | Up to Day 23 |
| Apparent volume of distribution of terminal phase (Vz/F) | Up to Day 23 |
| Cmax | Up to Day 23 |
| Area under the plasma concentration-time curve over one dosing interval (AUC(TAU)) | Up to Day 23 |
| Trough observed plasma concentration (Ctrough) | Up to Day 23 |
Countries
United States
Outcome results
None listed