Healthy Volunteers
Conditions
Brief summary
This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the drug levels of selected BMS-986435 tablet formulations will also be evaluated.
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 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must have a body weight of ≥ 45 kg and BMI between 18 and 32 kg/m2, inclusive * Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory assessments * Participants must have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality at screening, as determined by local transthoracic echocardiogram (TTE) assessment * Other protocol-defined Inclusion/
Exclusion criteria
apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) | Up to Day 28 |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Day 28 |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve truncated at 72-hour (AUC(0-72h)) | Up to Day 28 |
| Time of maximum observed concentration (Tmax) | Up to Day 28 |
| Half-life (T-HALF) | Up to Day 28 |
| Apparent total body clearance (CLT/F) | Up to Day 28 |
| Volume of distribution of terminal phase (Vz/F) | Up to Day 28 |
| Number of participants with Adverse Events (AEs) | Up to Day 35 |
| Number of participants with Serious AEs (SAEs) | Up to Day 35 |
| Number of participants with clinical laboratory abnormalities | Up to Day 28 |
| Number of participants with vital sign abnormalities | Up to Day 28 |
| Number of participants with physical examination abnormalities | Up to Day 28 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 28 |
Countries
United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed