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CompletedNCT02922452Updated Dec 20, 2016

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

A Phase 1 interventional study of BMS-986141 and Dilitazem in Ischemic Stroke, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-20.

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
01

Study 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).

02

Conditions studied

  • Ischemic Stroke

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03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's enrollment of 16 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke 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.

04

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

Exclusion criteria

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
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-986141 and Dilitazem

    Drug: BMS-986141 · Drug: Dilitazem

Interventions

  • DrugBMS-986141

    Single dose BMS-986141 and Multiple doses of Dilitazem

  • DrugDilitazem

    Single dose BMS-986141 and Multiple doses of Dilitazem

06

What researchers measure

Primary outcomes

  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 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 in the study if the last]

07

Study locations

1 site
  • PPD Development
    Austin, Texas 78744, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02922452
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Oct 4, 2016
Start date
Sep 2016
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Dec 20, 2016

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 Dec 2016. You cannot join it, but the record below documents what was studied.

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