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CompletedNCT02959060Updated Jan 6, 2017

A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects

A Phase 1 interventional study of BMS-986177 and Rifampin in Thrombosis, sponsored by Bristol-Myers Squibb. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-06.

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 55 Years
Sex
All
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Study summary

This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)

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Conditions studied

  • Thrombosis

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03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 16 is below the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

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 55 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 30 kg/m2, inclusive and with normal kidney function.
  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-986177 plus 5 half-lives (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days after completion of BMS-986177 treatment.

Exclusion criteria

Exclusion Criteria:

  1. Any significant acute or chronic medical illness, including any other condition listed as a contraindication in the rifampin package insert
  2. History of recurrent headaches, dizziness, chronic diarrhea, gastroesophageal reflux disease, dyspepsia, gastrointestinal ulcer disease, recurrent urinary tract infections, hypermenorrhea and recurrent candida infections, abnormal bleeding, history of hemophilia, Rosenthal syndrome, FXIa deficiency, or other coagulopathies.
  3. Recent surgery, head injury, blood transfusion, systemic lupus erythamatous, aneurysm, drug or alcohol abuse and use of tobacco or nicotine containing products in past six months.
  4. 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
  5. History of allergy to BMS-986177, FXIa inhibitors , rifampin or related compounds
05

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-986177 and Rifampin

    Drug: BMS-986177 · Drug: Rifampin

Interventions

  • DrugBMS-986177

    Single dose of BMS-986177 and multiple doses of Rifampin

  • DrugRifampin

    Single dose of BMS-986177 and multiple doses of Rifampin

06

What researchers measure

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Days1-15

  2. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Days1-15

  3. Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))

    Time frame: Days1-15

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 Jan 6, 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
NCT02959060
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Nov 8, 2016
Start date
Nov 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jan 6, 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 Jan 2017. You cannot join it, but the record below documents what was studied.

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