Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants

Thrombosis Clinical Trial

Official title:

Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982707
• Other study ID #: CV010-013
• Status: Completed
• Phase: Phase 1
• Start date: March 1, 2018
• Est. completion date: September 28, 2018

Study information

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

Clinical Trial Summary

A single oral dose of BMS-986177 administered to subjects of mild hepatic impairment, moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics, safety, and tolerability in these subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 28, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Women not of childbearing potential (WNOCBP) and males. Women must have documented proof they are not of childbearing potential

• BMI of 20.0 to 38.0 kg/m2, inclusive

• Hepatic subjects classified as Child-Pugh mild (Class A) or Child-Pugh moderate (Class B) who have had no significant change to disease status in past 6 months and are on stable treatment regimen

• Healthy subjects must not have clinically significant deviations from normal in medical history, physical exam, ECGs, vital signs or clinical lab values

Exclusion Criteria:

• Evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation

• Use of corticosteroids, nonsteroidal anti-inflammatory compounds, aspirin or other antiplatelet agents or anticoagulants within 2 weeks of dosing

• Healthy subjects must not have used tobacco or have a history of drug or alcohol abuse within the last 6 months

• Subjects must not have a current or recent (within 3 months) GI disease that increases participant risk of GI bleeding or interferes with absorption of the study drug

Other protocol defined inclusion and exclusion criteria may apply

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• BMS-986177
Single oral dose

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Texas Liver Institute	San Antonio	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	Maximum observed plasma concentration (Cmax) of BMS-986177		Up to 5 days
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-987177		Up to 5 days
Primary	Area under the plasma concentration-time curve from time zero to the time the last quantifiable concentration (AUC(0-T)) of BMS-986177		Up to 5 days
Primary	Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177		Up to 5 days
Secondary	Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation		Screening until 30 days after discontinuation of dosing or subject's participation
Secondary	Number of participants with clinical laboratory abnormalities		Screening until 30 days after discontinuation of dosing or subject's participation
Secondary	Number of participants with clinically significant changes in electrical activity of the heart measured by electrocardiogram (ECG)		Screening until 30 days after discontinuation of dosing or subject's participation
Secondary	Number of participants with vital sign abnormalities		Screening until 30 days after discontinuation of dosing or subject's participation

External Links

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