Evaluate the Pharmacokinetics of BMS-986177 From Two Formulations in Healthy Participants

Thrombosis Clinical Trial

Official title:

A Study to Evaluate the Pharmacokinetics of BMS-986177 From Form A and Form B in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362437
• Other study ID #: CV010-020
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2017
• Last updated: March 13, 2018
• Start date: November 15, 2017
• Est. completion date: December 28, 2017

Study information

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

Clinical Trial Summary

Assess the pharmacokinetics (fasting and fed), safety, and tolerability of BMS-986177 following oral dosing of Form A and Form B

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 28, 2017
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body mass index 18.0 to 32.0 kg/m2, inclusive

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

Exclusion Criteria:

• Any significant acute or chronic medical illness

• Head injury in the last 2 years

• History of bleeding disorder including rectal bleeding (ie, hemorrhoids), spontaneous nosebleeds, etc.

Other protocol defined inclusion / exclusion criteria could apply

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• BMS-986177
Form A
• BMS-986177
Form B

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Ruddington	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)	Measured by plasma concentration	Up to 3 days
Primary	AUC from time zero to time of last quantifiable concentration (AUC(0-T))	Measured by plasma concentration	Up to 3 days
Primary	AUC from time zero extrapolated to infinite time (AUC(INF))	Measured by plasma concentration	Up to 3 days
Secondary	Incidence of Adverse Events (AEs)	Safety and tolerability as measured by incidence of AEs	Up to 12 days
Secondary	Incidence of Serious Adverse Events (SAEs)	Safety and tolerability as measured by incidence of SAEs	Up to 30 days
Secondary	Number of participants with electrocardiogram abnormalities		Up to 12 days
Secondary	Number of participants with physical examination abnormalities		Up to 12 days
Secondary	Number of participants with clinical laboratory abnormalities		Up to 12 days

External Links

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