CV004-007 Thrombosis Chamber Study

NCT ID: NCT02439190

Last Updated: 2016-09-08

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-03-31

Brief Summary

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The purpose of this study is to determine whether BMS-986120, aspirin, or aspirin and clopidogrel decrease blood clotting.

Detailed Description

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Conditions

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Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Treatment A: BMS-986120

BMS-986120 on specified days

Group Type ACTIVE_COMPARATOR

BMS-986120

Intervention Type DRUG

Treatment B: Aspirin and Clopidogrel

Aspirin and Clopidogrel on specified days

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Interventions

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BMS-986120

Intervention Type DRUG

Aspirin

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive. BMI = weight (kg)/ \[height (m)\]2
* Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 65, inclusive
* Azoospermic males and women who are not of child-bearing potential (i.e. are postmenopausal or surgically sterile; see section 3.3.3 for the definition of WOCBP) are exempt from contraceptive requirements. However, women must still undergo pregnancy testing as described in this section

Exclusion Criteria

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
* Any condition that could affect drug absorption
Minimum Eligible Age

18 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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Local Institution

Edinburgh, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

References

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Wilson SJ, Ismat FA, Wang Z, Cerra M, Narayan H, Raftis J, Gray TJ, Connell S, Garonzik S, Ma X, Yang J, Newby DE. PAR4 (Protease-Activated Receptor 4) Antagonism With BMS-986120 Inhibits Human Ex Vivo Thrombus Formation. Arterioscler Thromb Vasc Biol. 2018 Feb;38(2):448-456. doi: 10.1161/ATVBAHA.117.310104. Epub 2017 Dec 21.

Reference Type DERIVED
PMID: 29269513 (View on PubMed)

Related Links

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Other Identifiers

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CV004-007

Identifier Type: -

Identifier Source: org_study_id

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