RecruitingPhase 1NCT07185113

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


Sponsor

GEn1E Lifesciences

Enrollment

6 participants

Start Date

Oct 29, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and how the body processes a new experimental drug called GEn-1124 after a single oral dose, in healthy adult men. This is an early-phase trial to understand how the drug is absorbed and eliminated from the body. **You may be eligible if...** - You are a healthy man aged 18–55 - Your BMI is between 18 and 32 - You are willing to follow all study rules, including dietary restrictions and exercise limitations **You may NOT be eligible if...** - You are taking prohibited medications or have significant health conditions - You use tobacco or nicotine products regularly - You have consumed caffeine or alcohol recently - You have had a major surgery or hospital stay in the past 30 days - You have participated in another drug trial in the past 90 days - You are an employee or family member of the study site Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGEn-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.


Locations(1)

New Zealand Clinical Research (NZCR)

Christchurch, New Zealand

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NCT07185113


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