Study to Evaluate the Effect of Rifampin on the Drug Levels in Blood and Safety of BMS-986235 in Healthy Participants

Phase 1

Withdrawn

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986235 (Treatment A); Drug: Rifampin (Treatment B)

• Registration Number: NCT04301310
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to examine the effect of rifampin on the drug levels in blood and safety of BMS-986235, when taken by healthy participants.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-06
• Study Start: 2020-03-09
• Study First Posted: 2020-03-10
• Primary Completion: 2020-03-16
• Study Completion: 2020-03-16
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations; no significant findings in medical history.
• Body mass index of 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening
• Males must agree to follow specific methods of contraception, if applicable

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Exclusion Criteria

• Women of childbearing potential (WOCBP)
• Known previous exposure to BMS-986235
• History of any significant drug allergy

Other protocol-defined inclusion/exclusion criteria apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	BMS-986235 (Treatment A)	-
Treatment Group	Rifampin (Treatment B)	-

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of BMS-986235	Day 1
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235	Day 1
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235	Day 1
Cmax of BMS-986235 with rifampin	Day 10
AUC(0-T) of BMS-986235 with rifampin	Day 10
AUC(INF) of BMS-986235 with rifampin	Day 10

Secondary Outcome Measures

Name	Time	Method
Incidence of clinically significant changes in electrocardiogram (ECG) parameters	Up to 41 days
Incidence of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))	Up to 41 days
Incidence of Serious Adverse Events (SAEs)	Up to 74 days
Incidence of clinically significant changes from baseline in physical examination findings	Up to 41 days
Incidence of clinically significant changes in vital signs: Body temperature	Up to 41 days
Incidence of clinically significant changes in vital signs: Heart rate	Up to 41 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Up to 41 days
Incidence of Nonserious Adverse Events (AEs)	Up to 46 days
Incidence of AEs leading to discontinuation	Up to 13 days
Incidence of clinically significant changes in vital signs: Respiratory rate	Up to 41 days
Incidence of clinically significant changes in vital signs: Blood pressure	Up to 41 days
Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests	Up to 41 days

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Salt Lake City, Utah, United States