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

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Cross-over Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986177 (an Oral Antithrombotic) With Single and Dual Antiplatelet Therapy (Aspirin and Clopidogrel) in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698513
• Other study ID #: CV010-034
• Status: Completed
• Phase: Phase 1
• Start date: October 4, 2018
• Est. completion date: February 19, 2019

Study information

• Verified date: September 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: February 19, 2019
• Est. primary completion date: February 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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.

Other protocol-defined inclusion/exclusion criteria apply.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BMS-986177
BMS-986177 capsule

Other:
• Placebo (for BMS-986177)
BMS-986177 placebo match capsule

Drug:
• Clopidogrel
Clopidogrel tablet
• Aspirin
Aspirin tablet

Locations

Country	Name	City	State
United States	PPD Development, LP	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)		Up to Day 33
Primary	Incidence of Serious Adverse Events (SAEs)		Up to Day 95
Primary	Incidence of Adverse Events (AEs) leading to discontinuation		Up to Day 33
Primary	Number of participants with vital sign abnormalities		Up to Day 33
Primary	Number of participants with 12-lead electrocardiogram (ECG) abnormalities		Up to Day 33
Primary	Number of participants with clinical laboratory abnormalities		Up to Day 33
Primary	Number of participants with physical examination abnormalities		Up to Day 33
Secondary	Maximum observed plasma concentration (Cmax)	Cmax of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite	Up to Day 33
Secondary	Area under the plasma concentration time curve in one dosing interval [AUC(TAU)]	AUC(TAU) of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite	Up to Day 33
Secondary	Time of maximum observed concentration (Tmax)	Tmax of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite	Up to Day 33
Secondary	Terminal plasma half-life (T-HALF)	T-Half of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite	Up to Day 33
Secondary	Trough observed plasma concentration (Ctrough)	Ctrough of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite	Up to Day 26
Secondary	Apparent total body clearance (CLT/F)	CLT/F of BMS-986177, aspirin, clopidogrel	Up to Day 33
Secondary	Volume of distribution (Vz/F)	Vz/F of BMS-986177, aspirin, clopidogrel	Up to Day 33

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form