A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05932277
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiogram (ECG), and clinical laboratory determinations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -1).
- Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg. BMI may be rounded.
Exclusion Criteria
- Any significant acute or chronic medical conditions or any significant acute or chronic medical illness as determined by the investigator
- Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery that could impact the absorption of study intervention
Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cocktail Probe Substrates + BMS-986419 BMS-986419 - Cocktail Probe Substrates + BMS-986419 Caffeine - Cocktail Probe Substrates + BMS-986419 Bupropion - Cocktail Probe Substrates + BMS-986419 Flurbiprofen - Cocktail Probe Substrates + BMS-986419 Omeprazole - Cocktail Probe Substrates + BMS-986419 Midazolam - Cocktail Probe Substrates + BMS-986419 Fexofenadine -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Up to Day 25 Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) Up to Day 25 Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) Up to Day 25
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) Up to Day 25 Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) Up to Day 25 Number of participants with Serious Adverse Events (SAEs) Up to 28 days after last dose Number of participants with clinical laboratory abnormalities Up to Day 25 Maximum observed plasma concentration (Cmax) Up to Day 25 Number of participants with Adverse Events (AEs) Up to 28 days after last dose Number of participants with AEs leading to discontinuation Up to 28 days after last dose Number of participants with vital sign abnormalities Up to Day 25 Number of participants with 12-lead ECG assessment abnormalities Up to Day 25 Number of participants with physical examination abnormalities Up to Day 25 Columbia-Suicide Severity Rating Scale (C-SSRS) Up to Day 25
Trial Locations
- Locations (1)
ICON Lenexa
🇺🇸Lenexa, Kansas, United States