Overview

A Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of BMS-986205 in Healthy Participants

Status:
Completed
Trial end date:
2019-07-20
Target enrollment:
0
Participant gender:
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 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
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