A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Different Degrees of Hepatic Impairment

Bristol-Myers Squibb (BMS)

Status and phase: Not yet enrolling; Phase 1

Conditions: Hepatic Impairment; Healthy Volunteers

Treatments: Drug: BMS-986435

Study type: Interventional

Funder types: Industry

Identifiers

NCT07248839

CV029-1017

Details and patient eligibility

About

The purpose of this study is to determine the pharmacokinetic and safety of BMS-986435 in participants with normal hepatic function and participants with different degrees of hepatic impairment

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant must have documented LVEF ≥ 60% (2D biplane Simpson's Method) and absence of cardiac abnormality.
• Participant must have body weight of > 50 kg and BMI of 18.0 kg/m2 through 40 kg/m2, inclusive, at screening.
• Participants must have adequate renal function at screening as evidenced by an eGFR > 60 mL/min/1.73 m2 for participants calculated with the CKD-EPI Creatinine Equation (2021).

Exclusion criteria

• Participants must not have history of or current uncontrolled or unstable clinically significant disorder, condition, or disease that, in the opinion of the investigator and CRO MM, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
• Participants must not have head injury in the last 2 years, intracranial tumor, or aneurysm.
• Participants must not have history of malignancy of any type, except in situ cervical cancer >5 years prior to the screening visit or surgically excised non-melanomatous skin cancer >2 years prior to the screening visit.
• Participants must not have History of heart disease (including coronary artery disease, heart failure/LV systolic dysfunction, cardiomyopathy, or clinically significant structural disease).
• Other protocol defined inclusion/exclusion criteria applies.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 3 patient groups

Arm A

Experimental group

Description:

Mild Hepatic Impairment

Treatment:

Drug: BMS-986435

Arm B

Experimental group

Description:

Moderate Hepatic Impairment

Treatment:

Drug: BMS-986435

Arm C

Experimental group

Description:

Matched participants with normal hepatic function

Treatment:

Drug: BMS-986435