RecruitingPhase 1NCT07472361

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


Sponsor

Engrail Therapeutics INC

Enrollment

12 participants

Start Date

Feb 25, 2026

Study Type

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

Min Age: 18 YearsMax Age: 64 Years

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

DRUGENX-104

Tablets

DRUGENX-104

Oral solution


Locations(1)

Parexel London EPCU

Middlesex, London, United Kingdom

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NCT07472361


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