A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects
Phase 1
Completed
- Conditions
- Malignancies Multiple
- Interventions
- Registration Number
- NCT03346837
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.
- Detailed Description
A randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of BMS-986205. Safety and tolerability data to be collected and assessed as well.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Inclusion Criteria
- Body mass index 18.0 to 32.0 kg/m2, inclusive
- Must have normal renal function demonstrated by GFR, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
- Women must not be of childbearing potential (cannot become pregnant)
Exclusion Criteria
- Any significant acute or chronic medical illness
- History of glucose-6-phosphodiesterase (G6PD) deficiency
- Personal or family history of cytochrome b5 reductase deficiency
Other protocol defined inclusion / exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhibition (Cohort 2) BMS-986205 Daily oral itraconazole doses for 24 days; single oral dose BMS-986205 on day 4 Induction (Cohort 3) BMS-986205 Single oral dose BMS-986205 Inhibition (Cohort 1) BMS-986205 Single oral dose BMS-986205 Induction (Cohort 4) BMS-986205 Daily oral rifampin doses for21 days; single oral dose BMS-986205 on day 8 Induction (Cohort 4) Rifampin Daily oral rifampin doses for21 days; single oral dose BMS-986205 on day 8 Inhibition (Cohort 2) Itraconazole Daily oral itraconazole doses for 24 days; single oral dose BMS-986205 on day 4
- Primary Outcome Measures
Name Time Method AUC from time zero to time of last quantifiable concentration (AUC(0-T)) Up to 25 days Measured by plasma concentration
AUC from time zero extrapolated to infinite time (AUC(INF)) Up to 25 days Measured by plasma concentration
Maximum observed plasma concentration (Cmax) Up to 25 days Measured by plasma concentration
- Secondary Outcome Measures
Name Time Method Number of participants with electrocardiogram abnormalities Up to 25 days Incidence of Adverse Events (AEs) Up to 25 days Safety and tolerability as measured by incidence of AEs
Number of participants with physical examination findings abnormalities Up to 25 days Number of participants with clinical laboratory abnormalities Up to 25 days Incidence of Serious Adverse Events (SAEs) Up to 76 days Safety and tolerability as measured by incidence of SAEs
Trial Locations
- Locations (1)
PPD
🇺🇸Austin, Texas, United States