A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects

Phase 1

Completed

• Conditions: Atherothrombotic Diseases
• Interventions: Drug: BMS 986141; Drug: Rifampin

• Registration Number: NCT02957448
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This study is to evaluate the effect of multiple doses of rifampin on the single-dose PK of BMS 986141 with parameters like Cmax, AUC(INF), AUC(0-T), AUC(0-144h)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Signed Informed Consent
2. Healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.
3. Subjects with body mass index of 18 to 32 kg/m2, inclusive.
4. Women participants must have documented proof that they are not of childbearing potential.
5. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of Rifampin (1 day) plus 90 days for a total of 91 days post-treatment completion.

Exclusion Criteria

1. Acute or chronic medical illness, subjects with bleeding diathesis, gastroesophageal reflux disease, gastrointestinal ulcer, hepatic disease,coagulation disorder,dyspepsia and being reliant on contact lenses for vision for the duration of study treatment and for 2 days after discontinuation of study treatment (eyeglasses are allowed).
2. History of nausea, diarrhoea, recent surgery, use of tobacco or nicotine containing products, drug or alcohol use, periodontal disease, hemorrhoids with rectal bleeding and recent blood donation.
3. Prior exposure to BMS-986141 or prothrombin complex, any investigational product or placebo within 4 weeks of study treatment start, any prescription or over the counter drugs except those cleared by BMS clinical monitor.
4. History of hypersensitivity to BMS 986141, rifampin, any rifamycins or related compounds, or any component of the formulations
5. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS 986141 and Rifampin	BMS 986141	-
BMS 986141 and Rifampin	Rifampin	-

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) of BMS-986141	Days 1-22
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141	Days 1-22
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141	Days 1-22
Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141	Days 1-22

Secondary Outcome Measures

Name	Time	Method
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death	Screening- until 30 days after discontinuation of dosing or subject's participation