A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects

NCT ID: NCT02959060

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2016-12-31

Brief Summary

This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)

Conditions

Thrombosis

Study Design

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

Study Groups

BMS-986177 and Rifampin

Group Type: EXPERIMENTAL

BMS-986177

Intervention Type: DRUG

Single dose of BMS-986177 and multiple doses of Rifampin

Rifampin

Intervention Type: DRUG

Single dose of BMS-986177 and multiple doses of Rifampin

Interventions

BMS-986177

Single dose of BMS-986177 and multiple doses of Rifampin

Intervention Type: DRUG

Rifampin

Single dose of BMS-986177 and multiple doses of Rifampin

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 30 kg/m2, inclusive and with normal kidney function.

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 with BMS-986177 plus 5 half-lives (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days after completion of BMS-986177 treatment.

Exclusion Criteria

1. Any significant acute or chronic medical illness, including any other condition listed as a contraindication in the rifampin package insert

2. History of recurrent headaches, dizziness, chronic diarrhea, gastroesophageal reflux disease, dyspepsia, gastrointestinal ulcer disease, recurrent urinary tract infections, hypermenorrhea and recurrent candida infections, abnormal bleeding, history of hemophilia, Rosenthal syndrome, FXIa deficiency, or other coagulopathies.

3. Recent surgery, head injury, blood transfusion, systemic lupus erythamatous, aneurysm, drug or alcohol abuse and use of tobacco or nicotine containing products in past six months.

4. 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

5. History of allergy to BMS-986177, FXIa inhibitors , rifampin or related compounds

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 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

References

Perera V, Wang Z, Lubin S, Christopher LJ, Chen W, Xu S, Seiffert D, DeSouza M, Murthy B. Effects of rifampin on the pharmacokinetics and pharmacodynamics of milvexian, a potent, selective, oral small molecule factor XIa inhibitor. Sci Rep. 2022 Dec 23;12(1):22239. doi: 10.1038/s41598-022-25936-2.

Reference Type: DERIVED

PMID: 36564395 (View on PubMed)

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

CV010-014

Identifier Type: -

Identifier Source: org_study_id