Clinical trial NCT04301310: Study to Evaluate the Effect of Rifampin on the Drug Levels in Blood and Safety of BMS-986235 in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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/exclusion criteria apply

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of BMS-986235
timeFrame: Day 1
measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235
timeFrame: Day 1
measure: Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235
timeFrame: Day 1
measure: Cmax of BMS-986235 with rifampin
timeFrame: Day 10
measure: AUC(0-T) of BMS-986235 with rifampin
timeFrame: Day 10
measure: AUC(INF) of BMS-986235 with rifampin
timeFrame: Day 10
Secondary outcomes:
measure: Incidence of Nonserious Adverse Events (AEs)
timeFrame: Up to 46 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 74 days
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 13 days
measure: Incidence of clinically significant changes from baseline in physical examination findings
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests
timeFrame: Up to 41 days
measure: Incidence of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))
timeFrame: Up to 41 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Local Institution
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: