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
GEn1E Lifesciences
6 participants
Oct 29, 2025
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
Inclusion Criteria8
- Healthy male subjects;
- Between 18 and 55 years of age;
- Provide a signed EC-approved consent form;
- Generally healthy, in the opinion of the Investigator;
- Body Mass Index (BMI) 18 to 32 kg/m\^2;
- Creatinine clearance with in specific parameter;
- Using method of contraception;
- Willing and able to comply with protocol requirements for the duration of the study.
Exclusion Criteria11
- Subjects taking prohibited medication;
- Subjects with a history or presence of clinically significant medical or psychiatric disease;
- Subjects who have regularly used nicotine-containing products ;
- Subjects who have used caffeine-containing products;
- Subjects who are unable to comply with eating a standardized meal during the study;
- Subjects with a hospital admission or major surgery within 30 days prior to Screening;
- Subjects with a plasma donation within 7 days prior to Screening;
- Subjects who have not abstained from alcoholic beverages/alcohol-containing products at least 72 hours prior to first dose, or plan to consume them at any time through completion of the Follow-up Visit;
- Subjects who cannot refrain from strenuous exercise from 72 hours prior to dose administration through completion of the Follow-up Visit;
- Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 90 days prior to Screening;
- Subjects who are employees of the study unit or their family members, students who are working in the study unit, or family members of the Investigator or Sponsor.
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07185113