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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04301310
• Other study ID #: CV018-023
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 9, 2020
• Est. completion date: March 16, 2020

Study information

• Verified date: March 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986235 (Treatment A)
Specified dose on specified days
• Rifampin (Treatment B)
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of BMS-986235		Day 1
Primary	Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235		Day 1
Primary	Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235		Day 1
Primary	Cmax of BMS-986235 with rifampin		Day 10
Primary	AUC(0-T) of BMS-986235 with rifampin		Day 10
Primary	AUC(INF) of BMS-986235 with rifampin		Day 10
Secondary	Incidence of Nonserious Adverse Events (AEs)		Up to 46 days
Secondary	Incidence of Serious Adverse Events (SAEs)		Up to 74 days
Secondary	Incidence of AEs leading to discontinuation		Up to 13 days
Secondary	Incidence of clinically significant changes from baseline in physical examination findings		Up to 41 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 41 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 41 days
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 41 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 41 days
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters		Up to 41 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 41 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests		Up to 41 days
Secondary	Incidence of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))		Up to 41 days

External Links

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