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

A Study to Evaluate the Effect of Coadministration of a Proton Pump Inhibitor (Omeprazole) on the Pharmacokinetics of BMS-986205 in Healthy Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03936374
Enrollment
16
Registered
2019-05-03
Start date
2019-05-08
Completion date
2019-07-20
Last updated
2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

Participants will receive BMS-986205 on Days 1 and 15

DRUGomeprazole

Participants will receive omeprazole on Days 10 to 15

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Maximum Observed Plasma Concentration (Cmax) of BMS-986205Up to Day 29
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986205Up to Day 29
Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]Up to Day 29

Secondary

MeasureTime frame
Number of Participants with Physical Examination AbnormalitiesUp to Day 29
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to DiscontinuationUp to Day 36
Number of Participants with Clinical Laboratory Results AbnormalitiesUp to Day 29
Number of Participants with Vital Sign AbnormalitiesUp to Day 29
Number of Participants with 12-lead Electrocardiogram (ECG) AbnormalitiesUp to Day 29

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026