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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Navlimetostat
DrugSpecified dose on specified days
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Treatment AExperimental treatment 1 intervention
Group B: Treatment BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Plasma Concentration (Cmax)
Time frame
Up to Day 172
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame
Up to Day 173
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame
Up to Day 174
Number of participants with Adverse Events (AE)
Time frame
Up to approximately day 37Secondary outcomes
1
Time of maximum observed drug concentration (Tmax)
Time frame
Up to Day 172
Terminal elimination half-life (T-HALF)
Time frame
Up to Day 173
Apparent total body clearance (CLT/F)
Time frame
Up to Day 174
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame
Up to Day 17Sponsors and contacts
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Source ClinicalTrials.gov