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

NCT ID: NCT02957448

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-01-31

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)

Conditions

Atherothrombotic Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

BMS 986141 and Rifampin

Group Type: EXPERIMENTAL

BMS 986141

Intervention Type: DRUG

Two single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)

Rifampin

Intervention Type: DRUG

Two single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)

Interventions

BMS 986141

Two single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)

Intervention Type: DRUG

Rifampin

Two single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

http://www.bms.com/studyconnect/pages/home.aspx

BMS Clinical Trial Education Resource

http://www.fda.gov/Safety/Recalls/

FDA Safety Alerts and Recalls

http://www.bms.com/clinical_trials/pages/investigator_inquiry_form.aspx

Investigator Inquiry Form

Other Identifiers

CV006-029

Identifier Type: -

Identifier Source: org_study_id