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

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ClinicalTrials.gov Identifier: NCT02957448
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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)

Condition or disease Intervention/treatment Phase
Atherothrombotic Diseases Drug: BMS 986141 Drug: Rifampin 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 Rifampin on the Single-dose Pharmacokinetics of BMS-986141 in Healthy Subjects
Study Start Date : November 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin

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)




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BMS-986141 [ Time Frame: Days 1-22 ]
  2. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141 [ Time Frame: Days 1-22 ]
  3. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141 [ Time Frame: Days 1-22 ]
  4. Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141 [ Time Frame: Days 1-22 ]

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 ]


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 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

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): NCT02957448


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: NCT02957448     History of Changes
Other Study ID Numbers: CV006-029
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers