A Study of ENX-104 in Healthy Participants
A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of ENX-104 Administered Orally as a Solution Fasted, a Tablet Fasted, or a Tablet With a High Fat Meal in Healthy Participants
Engrail Therapeutics INC
12 participants
Feb 25, 2026
INTERVENTIONAL
Conditions
Summary
The study is designed to evaluate the relative bioavailability, safety, and tolerability of a single dose of ENX-104 administered orally as a solution fasted, a tablet fasted, or a tablet with a high fat meal in healthy participants
Eligibility
Inclusion Criteria2
- Biologically female participants (defined as assigned female at birth): a) Of non-childbearing potential, (Note: For female participants with Follicle-Stimulating Hormone \[FSH\] levels that are not consistent with postmenopausal status, enrollment will be at the Investigator's discretion and will require a negative pregnancy test Screening and Admission \[Day -1\]); b) Of childbearing potential and willing to use highly effective methods of contraception, from Screening until 180 days after the last exposure to study drug, and with a negative pregnancy test at Screening and Admission (Day -1); c) Not currently breastfeeding or lactating, and not intending to initiate breastfeeding during the course of study conduct
- Biologically male participants (defined as assigned male at birth), if fertile, must be willing to use highly effective contraception, from first Screening through to 3 months after the last dose of study drug
Exclusion Criteria1
- Is unable or unwilling to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, should not participate in the study
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Interventions
Tablets
Oral solution
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07472361