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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BMS-986205; Drug: omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03936374

CA017-089

Details and patient eligibility

About

The purpose of this study is to assess the effect of multiple dose administrations of Omeprazole on the pharmacokinetics of BMS-986205.

Enrollment: 16 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

BMS-986205 + Omeprazole

Experimental group

Treatment:

Drug: omeprazole

Drug: BMS-986205