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

NCT03936374 | Completed Phase 1 FDA Drug

• 1 other identifier: CA017-089
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (1)

BMS-986205 + Omeprazole

EXPERIMENTAL

Drug: BMS-986205; Drug: omeprazole

Interventions

BMS-986205 DRUG

Participants will receive BMS-986205 on Days 1 and 15

BMS-986205 + Omeprazole

omeprazole DRUG

Participants will receive omeprazole on Days 10 to 15

BMS-986205 + Omeprazole

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PPD Phase I Clinic

Austin, Texas, 78744, United States

Location

Related Links

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

MeSH Terms

Interventions

linrodostat; Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Antonia Davidson, MD

  PPD Development, LP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: May 8, 2019
• Primary Completion: July 20, 2019
• Study Completion: July 20, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)