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

An Open-Label, Single-Sequence Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986141 in Healthy Subjects

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)

Study Overview

• Status: Completed
• Conditions: Atherothrombotic Diseases
• Intervention / Treatment: Drug: BMS 986141; Drug: Rifampin

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS 986141 and Rifampin	Drug: BMS 986141; Two single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22); Drug: Rifampin; Two single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Education Resource
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 21, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin
• Other Study ID Numbers: CV006-029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED