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A Study to Assess Administration of an Oral Anti-thrombotic With Antiplatelet Therapy in Healthy Subjects

NCT ID: NCT03698513

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-04

Study Completion Date

2019-02-19

Brief Summary

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This study will investigate the safety and interaction of BMS-986177 in healthy volunteers, when administered with Aspirin and/or Clopidogrel

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BMS-986177 + Aspirin + Clopidogrel (Part 1)

BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

BMS-986177 capsule

Clopidogrel

Intervention Type DRUG

Clopidogrel tablet

Aspirin

Intervention Type DRUG

Aspirin tablet

BMS-986177 (Part 1)

BMS-986177 200 mg capsule twice daily (days 1-5)

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

BMS-986177 capsule

BMS-986177 placebo + Aspirin + Clopidogrel (Part 1)

BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg once daily (day 1) then 75 mg tablet once daily (days 2-5)

Group Type PLACEBO_COMPARATOR

Placebo (for BMS-986177)

Intervention Type OTHER

BMS-986177 placebo match capsule

Clopidogrel

Intervention Type DRUG

Clopidogrel tablet

Aspirin

Intervention Type DRUG

Aspirin tablet

BMS-986177 (Part 2)

BMS-986177 200 mg capsule twice daily (days 1-5)

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

BMS-986177 capsule

BMS-986177 placebo + Clopidogrel (Part 2)

BMS-986177 placebo match capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)

Group Type PLACEBO_COMPARATOR

Placebo (for BMS-986177)

Intervention Type OTHER

BMS-986177 placebo match capsule

Clopidogrel

Intervention Type DRUG

Clopidogrel tablet

BMS-986177 + Clopidogrel (Part 2)

BMS-986177 200 mg capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

BMS-986177 capsule

Clopidogrel

Intervention Type DRUG

Clopidogrel tablet

BMS-986177 (Part 3)

BMS-986177 200 mg capsule twice daily (days 1-5)

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

BMS-986177 capsule

BMS-986177 placebo + Aspirin (Part 3)

BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)

Group Type PLACEBO_COMPARATOR

Placebo (for BMS-986177)

Intervention Type OTHER

BMS-986177 placebo match capsule

Aspirin

Intervention Type DRUG

Aspirin tablet

BMS-986177 + Aspirin (Part 3)

BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

BMS-986177 capsule

Aspirin

Intervention Type DRUG

Aspirin tablet

Interventions

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BMS-986177

BMS-986177 capsule

Intervention Type DRUG

Placebo (for BMS-986177)

BMS-986177 placebo match capsule

Intervention Type OTHER

Clopidogrel

Clopidogrel tablet

Intervention Type DRUG

Aspirin

Aspirin tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must have a Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
* Must have a normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) of \> 80 mL/min/1.73 m2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula and the absence of protein in the urine

For Parts 1 and 2:

• Must be a clopidogrel responder (eg, a decrease in platelet aggregation of at least 30% after a single 600-mg dose of clopidogrel compared with baseline).

Exclusion Criteria

* Any significant acute or chronic medical illness, including tinnitus or any other condition listed as a contraindication in the aspirin package insert.
* History of dizziness and/or recurrent headaches (i.e. daily headaches lasting for 1 week's duration in the last month prior to study treatment administration).
* History of head injury in the last 2 years, including participants with base skull fractures, intracranial tumor, or aneurysm.
* History of gastroesophageal reflux disease, dyspepsia (indigestion), protracted nausea, or chronic diarrhea (defined as 3 or 4 loose stools per day that last for ≥ 4 weeks) within the past 6 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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PPD Development, LP

Austin, Texas, United States

Site Status

Countries

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United States

References

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Perera V, Abelian G, Luettgen J, Aronson R, Li D, Wang Z, Zhang L, Lubin S, Merali S, Murthy B. Safety, tolerability, pharmacokinetics and pharmacodynamics of milvexian with aspirin and/or clopidogrel in healthy participants. Sci Rep. 2024 Jul 18;14(1):16591. doi: 10.1038/s41598-024-67182-8.

Reference Type DERIVED
PMID: 39025971 (View on PubMed)

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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CV010-034

Identifier Type: -

Identifier Source: org_study_id

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