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

A Phase 1, Open-label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety, and Tolerability of BMS-986235 in Healthy Participants

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986235 (Treatment A); Drug: Rifampin (Treatment B)

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Group	Drug: BMS-986235 (Treatment A); Specified dose on specified days; Drug: Rifampin (Treatment B); Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Maximum plasma concentration (Cmax) 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

Outcome Measure	Time Frame
Incidence of Serious Adverse Events (SAEs)	Up to 74 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 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: 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 vital signs: Heart rate	Up to 41 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters	Up to 41 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Up to 41 days
Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2020
• Primary Completion (ACTUAL): March 16, 2020
• Study Completion (ACTUAL): March 16, 2020

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (ACTUAL): March 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin
• Other Study ID Numbers: CV018-023

Drug and device information, study documents

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