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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT02959060

Collaborator

(none)

Enrollment

Arm

Duration (Days)

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Thrombosis	Drug: BMS-986177 Drug: Rifampin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

An Open-Label, Single-Sequence Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects

Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986177 and Rifampin	Drug: BMS-986177 Single dose of BMS-986177 and multiple doses of Rifampin Drug: Rifampin Single dose of BMS-986177 and multiple doses of Rifampin

Arm

Intervention/Treatment

Experimental: BMS-986177 and Rifampin

Drug: BMS-986177

Single dose of BMS-986177 and multiple doses of Rifampin

Drug: Rifampin

Single dose of BMS-986177 and multiple doses of Rifampin

Outcome Measures

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) [Days1-15]
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [Days1-15]
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) [Days1-15]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Signed Informed Consent
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.
Subjects with body mass index of 18 to 30 kg/m2, inclusive and with normal kidney function.
Women participants must have documented proof that they are not of childbearing potential.
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:

Any significant acute or chronic medical illness, including any other condition listed as a contraindication in the rifampin package insert
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.
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.
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
History of allergy to BMS-986177, FXIa inhibitors , rifampin or related compounds

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT02959060

Other Study ID Numbers:

CV010-014

First Posted:

Nov 8, 2016

Last Update Posted:

Jan 6, 2017

Last Verified:

Jan 1, 2017

Additional relevant MeSH terms:

Thrombosis

Rifampin

Study Results

No Results Posted as of Jan 6, 2017