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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04301310

Enrollment

Registered

2020-03-10

Start date

2020-03-09

Completion date

2020-03-16

Last updated

2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

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.

Interventions

DRUGBMS-986235 (Treatment A)

Specified dose on specified days

DRUGRifampin (Treatment B)

Specified dose on specified days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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/

Design outcomes

Primary

Measure	Time frame
Maximum plasma concentration (Cmax) 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
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) 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

Measure	Time frame
Incidence of Nonserious Adverse Events (AEs)	Up to 46 days
Incidence of Serious Adverse Events (SAEs)	Up to 74 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026