CV004-007 Thrombosis Chamber Study

Phase 1

Completed

• Conditions: Thrombosis
• Interventions: Drug: BMS-986120; Drug: Aspirin; Drug: Clopidogrel

• Registration Number: NCT02439190
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-08
• Study Start: 2015-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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
• Other protocol-defined exclusion criteria could apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A: BMS-986120	BMS-986120	BMS-986120 on specified days
Treatment B: Aspirin and Clopidogrel	Aspirin	Aspirin and Clopidogrel on specified days
Treatment B: Aspirin and Clopidogrel	Clopidogrel	Aspirin and Clopidogrel on specified days

Primary Outcome Measures

Name	Time	Method
Change from baseline in thrombus area (post-treatment with BMS-986120 vs. pre-treatment)	2 days

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of BMS 986120 or aspirin administered with and without clopidogrel based on adverse events,clinical laboratory tests, physical examinations and vital signs per the collection schedule	2 days

Trial Locations

Locations (1)

Local Institution; 🇬🇧 Edinburgh, Scotland, United Kingdom