CClinicalTrials.gg
CompletedNCT02957448Updated Feb 23, 2017

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

A Phase 1 interventional study of BMS 986141 and Rifampin in Atherothrombotic Diseases, sponsored by Bristol-Myers Squibb. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
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Study 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)

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Conditions studied

  • Atherothrombotic Diseases
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In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    BMS 986141 and Rifampin

    Drug: BMS 986141 · Drug: Rifampin

Interventions

  • DrugBMS 986141

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

  • DrugRifampin

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

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What researchers measure

Primary outcomes

  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 outcomes

  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

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Study locations

No study locations are listed for this record.

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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02957448
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Nov 6, 2016
Start date
Nov 2016
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Feb 23, 2017

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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