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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07472361

Enrollment

Registered

2026-03-16

Start date

2026-02-25

Completion date

2026-03-19

Last updated

2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief 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

Interventions

DRUGENX-104

Tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame
Plasma Concentration of ENX-104	Up to Day 16

Secondary

Measure	Time frame
Number of Participants with Treatment Emergent Adverse Events (TEAEs)	Up to Day 22
Plasma Concentration of Metabolites of ENX-1014	Up to Day 16

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORDavid George Steel, MBChB

Parexel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026