Clinical Trials in the USA / NCT07544628
Recruiting
Phase 1
A Phase 1 Study of Navlimetostat Tablet Formulations
NCT07544628 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Healthy Participants
Investigational drug(s) / intervention(s)
Navlimetostat: Specified dose on specified days
Study 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
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/exclusion criteria applies.
Primary outcome measure(s)
- 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
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| CenExel iResearch - Decatur | Decatur | Georgia | Recruiting |
| Local Institution - 0003 | Decatur | Georgia | Withdrawn |
| Local Institution - 0001 | Austin | Texas | Withdrawn |
| Local Institution - 0004 | Austin | Texas | Not Yet Recruiting |
More Bristol-Myers Squibb trials in the USA
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07544628 on ClinicalTrials.gov ↗ ← All trials in the USA