Actively Recruiting
A Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects
Led by GEn1E Lifesciences · Updated on 2025-12-12
6
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
G
GEn1E Lifesciences
Lead Sponsor
I
InClin, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects
- Aged between 18 and 55 years
- Signed informed consent form approved by ethics committee
- Generally healthy as determined by the Investigator
- Body Mass Index (BMI) between 18 and 32 kg/m²
- Creatinine clearance within specific parameters
- Using an approved method of contraception
- Willing and able to follow all study requirements for the entire study duration
You will not qualify if you...
- Taking prohibited medications
- History or presence of significant medical or psychiatric diseases
- Regular use of nicotine-containing products
- Use of caffeine-containing products
- Unable to eat a standardized meal during the study
- Hospital admission or major surgery within 30 days before screening
- Plasma donation within 7 days before screening
- Alcohol consumption within 72 hours prior to dosing or plans to consume alcohol during the study
- Unable to refrain from strenuous exercise from 72 hours before dosing through follow-up
- Participation in another clinical trial within 90 days before screening
- Employment or family relationship with the study unit staff or the Investigator/Sponsor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
New Zealand Clinical Research (NZCR)
Christchurch, New Zealand, 8011
Actively Recruiting
Research Team
R
Ritu Lal, CEO, PhD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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