A Phase 1, Open-label, Randomized, 2-Treatment, 2-Period, Crossover Study to Assess the Bioequivalence of Navlimetostat Wet-Granulation Tablet Versus the Dry-Granulation Tablet Formulation in Healthy Adult Female (as Assigned at Birth) Participants Who Are Individuals Not of Childbearing Potential
Bristol-Myers Squibb
Summary
This study aims to compare the PK of Navlimetostat after administration of a wet-granulation tablet versus the dry-granulation tablet formulation in healthy adult female
Eligibility
- Age range
- 18–55 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Participants must be healthy adult INOCBP female with no clinically significant findings on medical history, PE, VS, 12-lead ECGs, or clinical laboratory determinations, as assessed by the investigator. * Participants must have BMI of 18.0 to 35.0 kg/m2. * Participants must have adequate laboratory test results for renal and hepatic function, as assessed by the investigator, defined as eGFR ≥ 90 mL/min/1.73m2 using the CKD-EPI equation (screening only), and total bilirubin, ALP, GGT, AST, ALT ≤ 1.5 × ULN. Exclusion Criteria: * Participant must not have any significant…
Interventions
- DrugNavlimetostat
Specified dose on specified days
Locations (3)
- CenExel iResearch - DecaturDecatur, Georgia
- Local Institution - 0003Decatur, Georgia
- PPDAustin, Texas