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

December 19, 2016 updated by: Bristol-Myers Squibb

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

This study is to evaluate the effect of dilitazem on the single-dose PK of BMS-986141 with parameters like Cmax, AUC(INF), and AUC(0-T).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78744
        • Ppd Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

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 with BMS-986141 plus 5 half-lives plus 90 days for a total of 100 days post-treatment completion.

Exclusion Criteria:

  1. Acute or chronic medical illness, subjects with bleeding diathesis, gastrointestinal ulcer, hepatic disease.
  2. History of nausea, diarrhoea, recent surgery, use of tobacco or nicotine containing products, drug or alcohol use, important arrhythmias, sinus bradycardia, chronic headaches, history of multiple events of dizziness, periodontal disease 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 allergy to BMS-986141, dilitazem or any other significant drug allergy or adverse reaction to anticoagulants or antiplatelets.
  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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMS-986141 and Dilitazem
Drug: BMS-986141
Single dose BMS-986141 and Multiple doses of Dilitazem
Drug: Dilitazem
Single dose BMS-986141 and Multiple doses of Dilitazem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration (Cmax)
Time Frame: Days 1-21
Days 1-21
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time Frame: Days 1-21
Days 1-21
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T))
Time Frame: Days 1-21
Days 1-21

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
Time Frame: Screening- until 30 days after discontinuation of dosing or subject's participation in the study if the last]
Screening- until 30 days after discontinuation of dosing or subject's participation in the study if the last]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

September 30, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV006-028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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