To Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants

Thrombosis Clinical Trial

Official title:

Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224260
• Other study ID #: CV010-011
• Status: Completed
• Phase: Phase 1
• Start date: June 28, 2017
• Est. completion date: November 7, 2017

Study information

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

Clinical Trial Summary

Access the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy Japanese participants after multiple doses are administered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 7, 2017
• Est. primary completion date: November 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Participants must be first-generation Japanese (born in Japan and not living outside of Japan for > 10 years; both parents must be ethnically Japanese)

• Body Mass Index 18.0 to 25.0 kg/m2, inclusive

• Women must not be of nonchildbearing potential (cannot become pregnant)

Exclusion Criteria:

• Any significant acute or chronic medical illness

• History of allergy to BMS-986177 or other factor Xia inhibitors and/or formulation excipients or history of any significant drug allergy (such as anaphylaxis or hepatotoxicity)

• History or evidence of abnormal bleeding or coagulation disorder

Other protocol defined inclusion and exclusion criteria apply

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• BMS-986177
Oral Suspension

Other:
• Matched Placebo
Oral Suspension

Locations

Country	Name	City	State
United States	West Coast Clinical Trials	Anaheim	California

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	Occurrence of Death	Measured by investigator assessment	30 days after last dose
Primary	Incidence of Serious Adverse Events (SAEs)	Measured by investigator assessment	30 days after last dose
Primary	Incidence of Adverse Events (AEs) Leading to Discontinuation of Study Therapy	Measured by investigator assessment	17 days
Primary	Incidence of Adverse Events (AEs) Resulting in Clinically Significant Bleeding	Measured by investigator assessment	17 days
Primary	Changes in Vital Signs (heart rate, systolic blood pressure, diastolic blood pressure, respiration rate, and temperature)	Measured by investigator assessment	17 days
Primary	Change from baseline in electrocardiogram findings (ECGs)	Measured by investigator assessment	17 days

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form