Safety and Tolerability Study of BMS-986177 in Healthy Subjects

Thrombosis Clinical Trial

Official title:

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BMS-986177 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608970
• Other study ID #: CV010-001
• Secondary ID: 2015-003065-29
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2015
• Last updated: July 27, 2017
• Start date: December 31, 2015
• Est. completion date: July 23, 2017

Study information

• Verified date: July 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 23, 2017
• Est. primary completion date: July 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations

• Body Mass Index (BMI) of 18 to 30 kg/m2 inclusive. BMI = weight (kg)/ [height (m)]2

• Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 55, inclusive

Exclusion Criteria:

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population

• Any condition that could affect drug absorption

• Other protocol-defined exclusion criteria could apply

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• BMS-986177

Other:
• Placebo

Locations

Country	Name	City	State
Belgium	SGS Belgium NV	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of single dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations	Adverse event (AE), Serious adverse event (SAE)	Approximately 3 days
Primary	Safety of multiple dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations		Approximately 16 days
Primary	Tolerability of single dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations		Approximately 3 days
Primary	Tolerability of multiple dose of BMS-986177 measured by number of subjects who experience SAE, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations		Approximately 16 days

External Links

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