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Completed

NCT Number: NCT03936374

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

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

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Phase I Clinic

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986205

Drug

Participants will receive BMS-986205 on Days 1 and 15

Omeprazole

Drug

Participants will receive omeprazole on Days 10 to 15

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of BMS-986205

    Time frame: Up to Day 29

  2. Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986205

    Time frame: Up to Day 29

  3. Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]

    Time frame: Up to Day 29

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation

    Time frame: Up to Day 36

  2. Number of Participants with Vital Sign Abnormalities

    Time frame: Up to Day 29

  3. Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities

    Time frame: Up to Day 29

  4. Number of Participants with Physical Examination Abnormalities

    Time frame: Up to Day 29

  5. Number of Participants with Clinical Laboratory Results Abnormalities

    Time frame: Up to Day 29

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 3, 2019
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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