Healthy VolunteersPhase 1NCT07248839

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

A Phase 1 study testing BMS-986435 in people with Healthy Volunteers and Hepatic Impairment, run by Bristol-Myers Squibb at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Hepatic Impairment
What is being tested?: BMS-986435
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 3 sitesUnited States
Study dates: 15 Dec 2025to 20 Aug 2026
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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 locations and contacts

3 sites in 1 country.

United States3 sites

Local Institution - 0003
Chandler, Arizona, 85225
Local Institution - 0002
Miami Lakes, Florida, 33014
Local Institution - 0001
San Antonio, Texas, 78215

Other trials in United States

About this study

Official title: A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Mild and Moderate Hepatic Impairment

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

Conditions: Healthy Volunteers, Hepatic Impairment
Being tested: BMS-986435

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMS-986435Drug
Also called MYK-224
Specified dose on specified days

Study groups in NCT07248839
Study group	Role	What they receive
Arm A	Experimental	Mild Hepatic Impairment Receives: Drug: BMS-986435
Arm B	Experimental	Moderate Hepatic Impairment Receives: Drug: BMS-986435
Arm C	Experimental	Matched participants with normal hepatic function Receives: Drug: BMS-986435

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum observed concentration (Cmax)
Measured: Up to Day 45
Area under the concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
Measured: Up to Day 45
Area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF)
Measured: Up to Day 45

Secondary outcomes (6)

Number of participants with adverse events (AEs)
Measured: Up to Day 45
Number of participants with serious adverse events (SAEs)
Measured: Up to Day 45
Time of maximum observed concentration (Tmax)
Measured: Up to Day 45
Half-life (T-HALF)
Measured: Up to Day 45
Apparent total body clearance (CLT/F)
Measured: Up to Day 45
Apparent volume of distribution at terminal phase (Vz/F)
Measured: Up to Day 45

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202520 Aug 2026

First posted25 Nov 2025
Study start15 Dec 2025
Primary completion20 Aug 2026
Study completion20 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07248839
Sponsor's protocol ID: CV029-1017
Status last verified: Sep 2026
First submitted: 18 Nov 2025
Last updated: 21 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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