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A Study of ENX-104 in Healthy Participants | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07472361•Engrail Therapeutics INC

View on ClinicalTrials.gov

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

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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 Criteria

•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

Locations (1)

Parexel London EPCU

Middlesex, London, United Kingdom

Key Dates

Start Date

February 25, 2026

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

March 16, 2026

Enrollment

ESTIMATED participants

Conditions

Healthy Volunteers

Interventions

ENX-104

DRUG

ENX-104

DRUG

Contacts

Eve M Taylor, PHD

CONTACT

18583425478 eve.taylor@engrail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ENX-104 in Healthy Participants

Inclusion Criteria

Exclusion Criteria

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