Healthy Volunteers, Hepatic Impairment
Conditions
Brief 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
Interventions
DRUGBMS-986435
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) | Up to Day 45 |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T) | Up to Day 45 |
| Area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF) | Up to Day 45 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to Day 45 |
| Number of participants with serious adverse events (SAEs) | Up to Day 45 |
| Time of maximum observed concentration (Tmax) | Up to Day 45 |
| Half-life (T-HALF) | Up to Day 45 |
| Apparent total body clearance (CLT/F) | Up to Day 45 |
| Apparent volume of distribution at terminal phase (Vz/F) | Up to Day 45 |
Countries
United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain the NCT# and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed