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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BMS-986205; Drug: omeprazole

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Phase I Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986205 + Omeprazole	Drug: BMS-986205; Participants will receive BMS-986205 on Days 1 and 15; Drug: omeprazole; Participants will receive omeprazole on Days 10 to 15

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation	Up to Day 36
Number of Participants with Vital Sign Abnormalities	Up to Day 29
Number of Participants with 12-lead Electrocardiogram (ECG) 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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Principal Investigator: Antonia Davidson, MD, PPD

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Actual): July 20, 2019
• Study Completion (Actual): July 20, 2019

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 1, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole; Linrodostat
• Other Study ID Numbers: CA017-089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No