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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04225936
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 5
• Actual Duration (Months): 16.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment	Drug: BMS-986263	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 16, 2020
• Actual Primary Completion Date: Jun 1, 2021
• Actual Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A: Mild Hepatic Impairment Part 1	Drug: BMS-986263; Single Dose
Experimental: Group B: Moderate Hepatic Impairment Part 1	Drug: BMS-986263; Single Dose
Experimental: Group C: Severe Hepatic Impairment Part 2	Drug: BMS-986263; Single Dose
Experimental: Group D: Normal Hepatic function (control group) Part 1	Drug: BMS-986263; Single Dose
Experimental: Group E: Normal Hepatic Function (optional, control group) Part 2	Drug: BMS-986263; Single Dose

Outcome Measures

Primary Outcome Measures

1. Maximum observed serum concentration (Cmax) of components of BMS-986263 for injection [Day 1 to Day 31]

2. 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]

3. 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]

4. Total body clearance (CL) of components of BMS-986263 for injection [Day 1 to Day 31]

5. Volume of distribution (Vz) of components of BMS-986263 for injection [Day 1 to Day 31]

6. Terminal elimination half-life (T-Half) of components of BMS-986263 for injection [Day 1 to Day 31]

Secondary Outcome Measures

1. Incidence of Adverse Events (AEs) [Up to 31 days]

2. Incidence of Serious Adverse Events (SAEs) [Up to 59 days or up to 30 days after dosing (whichever is longer)]

3. 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).]

4. Number of participants with abnormalities in clinical laboratory assessments [Up to 59 days]

5. Number of participants with vital sign abnormalities [Up to 59 days]

6. Number of participants with 12-lead electrocardiogram (ECG) abnormalities [Up to 59 days]

7. Number of participants with physical examination abnormalities [Up to 59 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Texas Liver Institute	San Antonio	Texas	United States	78215

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04225936
• Other Study ID Numbers: IM025-015
• First Posted: Jan 13, 2020
• Last Update Posted: Nov 5, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases

Study Results

No Results Posted as of Nov 5, 2021