Single-dose oral GEn-1124 pharmacokinetics in healthy men

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

This will test how a single oral dose of GEn-1124 is processed by and tolerated in healthy adult men.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years to 55 Years
• Sex: Male
• Sponsor: GEn1E Lifesciences (Industry-sponsored)
• Locations: 1 site (Christchurch)
• Trial ID: NCT07185113 on ClinicalTrials.gov

What this trial studies

This Phase 1 study will dose approximately six healthy male volunteers with a single oral administration of GEn-1124 under fed conditions and monitor them closely. Participants will stay in clinic for about two days for blood sampling, ECGs, vital signs, and safety assessments, with phone checkups on days 3 and 7 and a follow-up visit around day 7. The trial will measure plasma levels of GEn-1124 and potential metabolites and calculate pharmacokinetic parameters using non-compartmental methods. Screening may begin up to 28 days before dosing and total on-study time excluding screening is roughly eight days.

Who should consider this trial

Good fit: Healthy adult men aged 18–55 with BMI 18–32 kg/m2 who meet screening labs, agree to contraception requirements, can eat a standardized meal, and can comply with the clinic stay are ideal candidates.

Not a fit: People with significant medical or psychiatric conditions, women, recent surgery or plasma donors, regular nicotine or caffeine users, those on prohibited medications, or anyone unable to follow dietary or clinic requirements are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If results show acceptable safety and predictable blood levels, this could inform dosing and safety for later trials of GEn-1124.

How similar studies have performed: Single-dose pharmacokinetic studies in healthy volunteers are a standard early step in drug development and have routinely characterized safety and dosing for many drugs, though no prior human data for GEn-1124 is provided here.

Eligibility criteria

Inclusion Criteria:

1. Healthy male subjects;
2. Between 18 and 55 years of age;
3. Provide a signed EC-approved consent form;
4. Generally healthy, in the opinion of the Investigator;
5. Body Mass Index (BMI) 18 to 32 kg/m\^2;
6. Creatinine clearance with in specific parameter;
7. Using method of contraception;
8. Willing and able to comply with protocol requirements for the duration of the study.

Exclusion Criteria:

1. Subjects taking prohibited medication;
2. Subjects with a history or presence of clinically significant medical or psychiatric disease;
3. Subjects who have regularly used nicotine-containing products ;
4. Subjects who have used caffeine-containing products;
5. Subjects who are unable to comply with eating a standardized meal during the study;
6. Subjects with a hospital admission or major surgery within 30 days prior to Screening;
7. Subjects with a plasma donation within 7 days prior to Screening;
8. 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;
9. Subjects who cannot refrain from strenuous exercise from 72 hours prior to dose administration through completion of the Follow-up Visit;
10. Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 90 days prior to Screening;
11. 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.

Where this trial is running

Christchurch

• New Zealand Clinical Research (NZCR) — Christchurch, New Zealand (Recruiting)

Study contacts

• Study coordinator: Ritu Lal, CEO, PhD, MS

Conditions Healthy Adult Male; GEn-1124; Healthy Volunteer