A Phase 1 Study of Navlimetostat Tablet Formulations
ConditionHealthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorBristol-Myers Squibb
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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/exclusion criteria applies.
Trial design
Treatments tested in this trial
- Navlimetostat
Treatment groups
64 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov