A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04634149
• Collaborator: (none)
• Enrollment: 16
• Locations: 3
• Arms: 3
• Actual Duration (Months): 18.3
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.

Condition or Disease	Intervention/Treatment	Phase
Moderate Liver Impairment; Severe Liver Impairment	Drug: BMS-986036	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Normal Hepatic Function and Participants With Moderate and Severe Hepatic Impairment
• Actual Study Start Date: Nov 23, 2020
• Actual Primary Completion Date: Jun 2, 2022
• Actual Study Completion Date: Jun 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A: Moderate Hepatic Impairment	Drug: BMS-986036; Specified dose on specified days
Experimental: Group B: Severe Hepatic Impairment	Drug: BMS-986036; Specified dose on specified days
Experimental: Group C: Normal Hepatic Function	Drug: BMS-986036; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) [Up to 29 days]

2. Time of maximum observed plasma concentration (Tmax) [Up to 29 days]

3. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) [Up to 29 days]

Secondary Outcome Measures

1. Number of participants with adverse events (AEs) [Up to 31 days]

2. Number of participants with clinical laboratory abnormalities [Up to 31 days]

3. Number of participants with vital sign abnormalities [Up to 31 days]

4. Number of participants with electrocardiogram (ECG) abnormalities [Up to 31 days]

5. Number of participants with physical examination abnormalities [Up to 31 days]

6. Maximum observed plasma concentration (Cmax) [Up to 29 days]

7. Time of maximum observed plasma concentration (Tmax) [Up to 29 days]

8. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration(AUC(0-T)) [Up to 29 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy participants or participants with hepatic impairment, as determined by medical history, physical exam, electrocardiogram (ECG), and clinical laboratory determinations

• Body mass index (BMI) of 18.0 kg/m^{2 to 40.0 kg/m}2, inclusive. BMI = weight (kg)/height (m^2)

Exclusion Criteria:

• Any history of known or suspected congenital or acquired immunodeficiency state or condition that would have compromised the participant's immune status

• History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution - 0002	Miami	Florida	United States	33014
2	Local Institution	Orlando	Florida	United States	32809
3	Local Institution - 0001	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: NCT04634149
• Other Study ID Numbers: MB130-112
• First Posted: Nov 18, 2020
• Last Update Posted: Jun 16, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Cirrhosis; Hepatic impairment; Liver impairment; Nonalcoholic steatohepatitis (NASH)

Study Results

No Results Posted as of Jun 16, 2022