A Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Liver Impairment

Hepatic Impairment Clinical Trial

Official title:

An Open-label, Two-Part, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Hepatic Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04225936
• Other study ID #: IM025-015
• Status: Completed
• Phase: Phase 1
• Start date: January 16, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: October 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the effect of liver impairment on the safety and pharmacokinetics (PK) of BMS-986263

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• BMI = 18 kg/m^2 and weight = 50 kg at screening (BMI = weight [kg]/height [m^2]).

• Participants with normal hepatic function as judged by the investigator

• Participants with hepatic impairment as judged by the investigator

Exclusion Criteria:

• Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant.

• Any major surgery within 4 weeks of study drug administration

• Previous exposure to BMS-986263

Other protocol-defined inclusion/exclusion criteria apply.

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• BMS-986263
Single Dose

Locations

Country	Name	City	State
United States	The 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 serum concentration (Cmax) of components of BMS-986263 for injection		Day 1 to Day 31
Primary	Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of components of BMS-986263 for injection		Day 1 to Day 31
Primary	Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of components of BMS-986263 for injection		Day 1 to Day 31
Primary	Total body clearance (CL) of components of BMS-986263 for injection		Day 1 to Day 31
Primary	Volume of distribution (Vz) of components of BMS-986263 for injection		Day 1 to Day 31
Primary	Terminal elimination half-life (T-Half) of components of BMS-986263 for injection		Day 1 to Day 31
Secondary	Incidence of Adverse Events (AEs)		Up to 31 days
Secondary	Incidence of Serious Adverse Events (SAEs)		Up to 59 days or up to 30 days after dosing (whichever is longer)
Secondary	Incidence of AEs leading to discontinuation		Nonserious AEs: Up to 31 days ; SAEs: Up to 59 days or up to 30 days after dosing (whichever is longer).
Secondary	Number of participants with abnormalities in clinical laboratory assessments		Up to 59 days
Secondary	Number of participants with vital sign abnormalities		Up to 59 days
Secondary	Number of participants with 12-lead electrocardiogram (ECG) abnormalities		Up to 59 days
Secondary	Number of participants with physical examination abnormalities		Up to 59 days

External Links

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