A PET Study of ENX-104 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-24

Study Completion Date

2025-09-02

Brief Summary

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The study is designed to evaluate the D2/D3 receptor occupancy (RO), safety, tolerability, and pharmacokinetics (PK) of ENX-104 in healthy volunteers.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ENX-104

Group Type EXPERIMENTAL

ENX-104

Intervention Type DRUG

Oral solution

Interventions

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ENX-104

Oral solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Biologically female participants (defined as assigned female at birth)

1. Of non-childbearing potential, defined as either permanently sterilized or postmenopausal and with a negative pregnancy test
2. 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 a condom or remain abstinent. Participants assigned male at birth should use a highly effective method of birth control and refrain from sexual activity with partners of childbearing potential who do not use a highly effective method of birth control during the study. Participants assigned male at birth who are not surgically sterilized for at least 90 days prior to Screening and are sexually active with partner(s) of childbearing potential, must agree to refrain from sperm donation.

Exclusion Criteria

* 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.

Minimum Eligible Age

23 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes