An Investigational Study to Assess the Effect of BMS-986177 on Aspirin in Healthy Participants

• ClinicalTrials.gov Identifier: NCT03341390
• Recruitment Status: Completed
• First Posted: November 14, 2017
• Last Update Posted: January 19, 2018
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

Brief Summary:

The purpose of this study is to investigate the effect of taking multiple doses of BMS-986177 when aspirin is taken once-daily. Eligible participants will receive twice-daily doses of BMS-986177 or placebo, with a once-daily dose of aspirin. The safety, tolerability and movement of BMS-986177 into, through and out of the body (pharmacokinetics/PK) will be assessed, as will the effect of BMS-986177 on the PK of aspirin.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: Aspirin; Drug: BMS-986177; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Coadministration of Multiple Doses of BMS-986177 on Aspirin in Healthy Participants
• Actual Study Start Date: October 18, 2017
• Actual Primary Completion Date: November 16, 2017
• Actual Study Completion Date: November 16, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Aspirin; 325 mg tablet, once daily for 5 days (Day -5 to -1)	Drug: Aspirin; 1 x 325 mg tablet of aspirin administered once daily; Other Name: Acetylsalicylic Acid
Experimental: BMS-986177 plus aspirin; 200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7)	Drug: Aspirin; 1 x 325 mg tablet of aspirin administered once daily; Other Name: Acetylsalicylic Acid; Drug: BMS-986177; 200 mg of BMS-986177 administered twice daily
Placebo Comparator: Placebo plus aspirin; 200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7)	Drug: Aspirin; 1 x 325 mg tablet of aspirin administered once daily; Other Name: Acetylsalicylic Acid; Drug: Placebo; 200 mg of Placebo administered twice daily

Outcome Measures

Primary Outcome Measures :

1. Number of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation when coadministered BMS-986177 (twice daily) and aspirin (once daily) [ Time Frame: Up to 10 days ]
   Safety and tolerability of multiple doses of BMS-986177 measured by investigator assessment
2. Number of potential clinically significant changes in electrical activity of the heart in participants coadministered BMS-986177 (twice daily) and aspirin (once daily) [ Time Frame: Up to 10 days ]
   Measured by electrocardiogram (ECG)
3. Number of participants with vital sign abnormalities. [ Time Frame: Up to 10 days ]
4. Number of participants with physical examination abnormalities. [ Time Frame: Up to 10 days ]
5. Number of participants with clinical laboratory abnormalities. [ Time Frame: Up to 10 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Signed written consent form.
• Healthy male and female participants (not of childbearing potential), determined by no clinically significant deviation from normal in medical history, physical examination, ECGs (electrocardiograms) and clinical laboratory determinations.
• Women participants must have documented proof they are not of childbearing potential.
• Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with BMS-986177, and for a total of 93 days after the last dose of BMS-986177; and must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements.
• Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2.
• Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2 inclusive.

Exclusion Criteria:

• Women who are of childbearing potential or breastfeeding.
• Any significant acute or chronic illness.
• History of gastroesophageal reflux disease, dyspepsia, protracted nausea or chronic diarrhea.
• History of upper gastrointestinal ulcer disease within 6 months or current symptomatic or recent gastrointestinal disease that could impact absorption of study treatment.
• Abnormal renal profile and/or hematuria (if male) within 3 months of study start.
• History or evidence of abnormal bleeding and/or coagulation disorder and/or evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation, or a history of spontaneous bleeding.
• Any major surgery within 4 weeks of study treatment administration or planned within 2 weeks after completion of the study.
• Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study treatment administration (within 2 weeks for plasma only).
• Blood transfusion within 3 months of study treatment administration.
• Use of tobacco- or nicotine-containing products (including, but not limited to cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges or nicotine gum) within 6 months prior to study treatment administration.
• History of allergy to aspirin or related compounds.

Other protocol-defined inclusion/exclusion criteria could apply.

Contacts and Locations

Locations

United States, Texas

PPD Austin Clinic

Austin, Texas, United States, 78744

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Additional Information:

FDA Safety Alerts and Recalls 

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03341390
• Other Study ID Numbers: CV010-027
• First Posted: November 14, 2017
• Last Update Posted: January 19, 2018
• Last Verified: January 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bristol-Myers Squibb:

Healthy participants; Healthy subjects; Strokes

Additional relevant MeSH terms:

Aspirin; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics