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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBristol-Myers Squibb

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • BMS-986435

    Drug

    Specified dose on specified days

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BExperimental treatment 1 intervention
Group C: Arm CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum observed concentration (Cmax)

Time frame
Up to Day 45
2

Area under the concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)

Time frame
Up to Day 45
3

Area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF)

Time frame
Up to Day 45

Secondary outcomes

1

Number of participants with adverse events (AEs)

Time frame
Up to Day 45
2

Number of participants with serious adverse events (SAEs)

Time frame
Up to Day 45
3

Time of maximum observed concentration (Tmax)

Time frame
Up to Day 45
4

Half-life (T-HALF)

Time frame
Up to Day 45

Other outcomes

Sponsors and contacts

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