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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341390
• Other study ID #: CV010-027
• Status: Completed
• Phase: Phase 1
• First received: October 30, 2017
• Last updated: January 17, 2018
• Start date: October 18, 2017
• Est. completion date: November 16, 2017

Study information

• Verified date: January 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 16, 2017
• Est. primary completion date: November 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Aspirin
1 x 325 mg tablet of aspirin administered once daily
• BMS-986177
200 mg of BMS-986177 administered twice daily
• Placebo
200 mg of Placebo administered twice daily

Locations

Country	Name	City	State
United States	PPD Austin Clinic	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	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)	Safety and tolerability of multiple doses of BMS-986177 measured by investigator assessment	Up to 10 days
Primary	Number of potential clinically significant changes in electrical activity of the heart in participants coadministered BMS-986177 (twice daily) and aspirin (once daily)	Measured by electrocardiogram (ECG)	Up to 10 days
Primary	Number of participants with vital sign abnormalities.		Up to 10 days
Primary	Number of participants with physical examination abnormalities.		Up to 10 days
Primary	Number of participants with clinical laboratory abnormalities.		Up to 10 days

External Links

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