Overview
A Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of BMS-986205 in Healthy Participants
Status:
Completed
Completed
Trial end date:
2019-07-20
2019-07-20
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to assess the effect of multiple dose administrations of Omeprazole on the pharmacokinetics of BMS-986205.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Bristol-Myers SquibbTreatments:
Linrodostat
Omeprazole
Criteria
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