Healthy Participants
Conditions
Keywords
Healthy adult female, Individuals not of childbearing potential, Open label study, Clinical Research Unit, Phase 1
Brief 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
Interventions
DRUGNavlimetostat
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
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 acute or chronic medical illness (in the assessment of the investigator). * Participant must not have current or recent GI disease: Any gastrointestinal disease within 3 months of study intervention administration that could possibly affect drug absorption, distribution, metabolism, and excretion (eg, bariatric procedure, history of pancreatitis, uncontrolled nausea or vomiting) in the opinion of the investigator. * Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) | Up to Day 17 |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] | Up to Day 17 |
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | Up to Day 17 |
| Number of participants with Adverse Events (AE) | Up to approximately day 37 |
| Number of participants with Serious Adverse Events (AE) | Up to approximately day 37 |
| Number of participants with clinically significant changes in Physical Examinations (PE) | Up to Day 17 |
| Number of participants with clinically significant changes in vital signs (VS) | Up to Day 17 |
| Number of participants with clinically significant changes in 12-lead ECGs | Up to Day 17 |
| Number of participants with clinically significant changes in laboratory tests results | Up to Day 17 |
Secondary
| Measure | Time frame |
|---|---|
| Time of maximum observed drug concentration (Tmax) | Up to Day 17 |
| Terminal elimination half-life (T-HALF) | Up to Day 17 |
| Apparent total body clearance (CLT/F) | Up to Day 17 |
| Apparent volume of distribution during the terminal phase (Vz/F) | Up to Day 17 |
| Mean residence time (MRT) | Up to Day 17 |
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