Clinical trial NCT03698513: A Study to Assess Administration of an Oral Anti-thrombotic With Antiplatelet Therapy in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to Day 33
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to Day 95
measure: Incidence of Adverse Events (AEs) leading to discontinuation
timeFrame: Up to Day 33
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 33
measure: Number of participants with 12-lead electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 33
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Day 33
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 33
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 33
measure: Area under the plasma concentration time curve in one dosing interval [AUC(TAU)]
timeFrame: Up to Day 33
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to Day 33
measure: Terminal plasma half-life (T-HALF)
timeFrame: Up to Day 33
measure: Trough observed plasma concentration (Ctrough)
timeFrame: Up to Day 26
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to Day 33
measure: Volume of distribution (Vz/F)
timeFrame: Up to Day 33
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: