Status:
RECRUITING
A Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects
Lead Sponsor:
GEn1E Lifesciences
Collaborating Sponsors:
InClin, Inc.
Conditions:
Healthy Adult Male
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT07185113
Start Date
October 29 2025
End Date
December 1 2025
Last Update
December 12 2025
Active Locations (1)
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1
New Zealand Clinical Research (NZCR)
Christchurch, New Zealand, 8011