NCT07185113

A Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects

A Phase 1, Single Dose, Open-label Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: GEn1E Lifesciences · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to determine the pharmacokinetics (how the body interacts with administered substances for the entire duration of exposure) of Gen-1124 in an oral formulation (taken by mouth) in healthy volunteers. It will also learn about the safety of Gen-1124. The main questions it aims to answer are: \- How does Gen-1124 interact with a human body? Researchers will look at how Gen-1124 interacts with the body and what side effects it may cause. Participants will: * Take Gen-1124 for a single dose * Remain in clinic for 2 days for checkups and tests * Recieve a phone call for a checkup 3 and 7 days after the single dose

Detailed description

Approximately 6 healthy male subjects who meet all eligibility criteria will be dosed. There will be one single dose group of subjects dosed under fed (standardized meal) conditions. Screening will be initiated up to 28 days before dosing. A follow-up visit will be completed approximately 7 days after dosing. Thus, total duration of subject participation in the study, excluding the Screening visit, will be approximately 8 days. The incidence of adverse events from the time of informed consent through the final follow-up visit (end of study). This will be based on the results of: * Physical exams, * Electrocardiography (ECG) results, * Clinical laboratory results, * Vital signs, * Concomitant medications. Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods.

Conditions

• Healthy Adult Male

Interventions

Type	Name	Description
DRUG	GEn-1124	GEn-1124 will be administered to one single dose group of subjects dosed under fed (standardized meal) conditions. GEn-1124 will be administered as an oral capsule formulation containing GEn-1124.

Timeline

• Start date: 2025-10-29
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-09-22
• Last updated: 2025-12-12

Locations

1 site across 1 country: New Zealand