A Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of BMS-986205 in Healthy Participants
- Registration Number
- NCT03936374
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the effect of multiple dose administrations of Omeprazole on the pharmacokinetics of BMS-986205.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Health male and female participants (not of childbearing potential) as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) greater than or equal to (>=) 80 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2)
- Body mass index (BMI) of 18.0 kilogram per meter square (kg/m^2) to 32.0 kg/m^2
- Women participants must have documented proof that they are not of childbearing potential
Exclusion Criteria
- Women who are of childbearing potential or breastfeeding
- Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years
- Concomitant use of strong inhibitors or strong inducers of CYP3A4
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-986205 + Omeprazole BMS-986205 - BMS-986205 + Omeprazole omeprazole -
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of BMS-986205 Up to Day 29 Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986205 Up to Day 29 Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)] Up to Day 29
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation Up to Day 36 Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities Up to Day 29 Number of Participants with Vital Sign Abnormalities Up to Day 29 Number of Participants with Physical Examination Abnormalities Up to Day 29 Number of Participants with Clinical Laboratory Results Abnormalities Up to Day 29
Trial Locations
- Locations (1)
PPD Phase I Clinic
🇺🇸Austin, Texas, United States