Healthy Volunteers
Conditions
Brief summary
The study is designed to evaluate the D2/D3 receptor occupancy (RO), safety, tolerability, and pharmacokinetics (PK) of ENX-104 in healthy volunteers.
Interventions
DRUGENX-104
Oral solution
Sponsors
Engrail Therapeutics INC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
23 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAE) | From Day 1 up to Day 9 |
Countries
United Kingdom
Outcome results
None listed