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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT03936374

Collaborator

(none)

Enrollment

Location

Arm

2.4

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BMS-986205 Drug: omeprazole	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 8, 2019

Actual Primary Completion Date :

Jul 20, 2019

Actual Study Completion Date :

Jul 20, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Phase I Clinic	Austin	Texas	United States	78744

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Principal Investigator: Antonia Davidson, MD, PPD

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT03936374

Other Study ID Numbers:

CA017-089

First Posted:

May 3, 2019

Last Update Posted:

Sep 23, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Omeprazole

Linrodostat

Study Results

No Results Posted as of Sep 23, 2019