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Tests treatment safety and results for Healthy Volunteers
Official title 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
ClinicalTrials.gov ID: NCT07248839
What this study is testing
What is BMS-986435?
BMS-986435 is an investigational medicine, being studied as a potential treatment for healthy volunteers.
Also referred to as MYK-224.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- Participants must not have history of or current uncontrolled or unstable clinically significant disorder, condition, or disease that, in the opinion...
- 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...
- Participants must not have History of heart disease (including coronary artery disease, heart failure/LV systolic dysfunction, cardiomyopathy, or...
- Other protocol defined inclusion/exclusion criteria applies.
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Miami Lakes, Florida, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Miami Lakes, Florida, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.