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Completed

NCT Number: NCT03698513

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

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development, LP

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986177

Drug

BMS-986177 capsule

Placebo (for BMS-986177)

Other

BMS-986177 placebo match capsule

clopidogrel

Drug

Clopidogrel tablet

Aspirin

Drug

Aspirin tablet

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to Day 33

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to Day 95

  3. Incidence of Adverse Events (AEs) leading to discontinuation

    Time frame: Up to Day 33

  4. Number of participants with vital sign abnormalities

    Time frame: Up to Day 33

  5. Number of participants with 12-lead electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 33

  6. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 33

  7. Number of participants with physical examination abnormalities

    Time frame: Up to Day 33

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 33

    Cmax of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite

  2. Area under the plasma concentration time curve in one dosing interval [AUC(TAU)]

    Time frame: Up to Day 33

    AUC(TAU) of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite

  3. Time of maximum observed concentration (Tmax)

    Time frame: Up to Day 33

    Tmax of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite

  4. Terminal plasma half-life (T-HALF)

    Time frame: Up to Day 33

    T-Half of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite

  5. Trough observed plasma concentration (Ctrough)

    Time frame: Up to Day 26

    Ctrough of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite

  6. Apparent total body clearance (CLT/F)

    Time frame: Up to Day 33

    CLT/F of BMS-986177, aspirin, clopidogrel

  7. Volume of distribution (Vz/F)

    Time frame: Up to Day 33

    Vz/F of BMS-986177, aspirin, clopidogrel

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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