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

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ClinicalTrials.gov Identifier: NCT02922452
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : December 20, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: BMS-986141 Drug: Dilitazem Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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 Diltiazem on the Single-Dose Pharmacokinetics of BMS-986141 in Healthy Subjects
Study Start Date : September 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Maximum observed concentration (Cmax) [ Time Frame: Days 1-21 ]
  2. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [ Time Frame: Days 1-21 ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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] ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922452


Locations
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United States, Texas
PPD Development
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02922452    
Other Study ID Numbers: CV006-028
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Diltiazem
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents