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

NCT02957448 | Completed Phase 1

• 1 other identifier: CV006-029
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 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

Study Arms (1)

BMS 986141 and Rifampin

EXPERIMENTAL

Drug: BMS 986141; Drug: Rifampin

Interventions

BMS 986141 DRUG

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

BMS 986141 and Rifampin

Rifampin DRUG

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

BMS 986141 and Rifampin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 32 kg/m2, inclusive.
• 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 plus 5 half-lives of Rifampin (1 day) plus 90 days for a total of 91 days post-treatment completion.

You may not qualify if:

• 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).
• 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.
• 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.
• History of hypersensitivity to BMS 986141, rifampin, any rifamycins or related compounds, or any component of the formulations
• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• BMS Clinical Trial Education Resource
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

MeSH Terms

Interventions

Rifampin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 7, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02