A Phase 1 Study of Navlimetostat Tablet Formulations
Recruiting now · Phase 1
Conditions studied: Healthy Participants
In brief
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
Key facts
- Study ID
- NCT07544628
- Run by
- Bristol-Myers Squibb
- People needed
- 64
- Starts
- 2026-04-27
- Expected to finish
- 2026-10-15
- Last updated by the study team
- 2026-06-24
Who can join
Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- CenExel iResearch - Decatur — Decatur, Georgia, United States (enrolling)
- Local Institution - 0003 — Decatur, Georgia, United States
- Local Institution - 0001 — Austin, Texas, United States
- Local Institution - 0004 — Austin, Texas, United States
Full record on ClinicalTrials.gov
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