A Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects

GEn1E Lifesciences

Status and phase: Enrolling; Phase 1

Conditions: Healthy Adult Male

Treatments: Drug: GEn-1124

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07185113

GEn-1124-003

Details and patient eligibility

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

Full 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 be initiated up to 28 days before dosing. A follow-up visit will be completed approximately 7 days after dosing. Thus, total duration of subject participation in the study, excluding the Screening visit, will be approximately 8 days.

The incidence of adverse events from the time of informed consent through the final follow-up visit (end of study). This will be based on the results of:

• Physical exams,
• Electrocardiography (ECG) results,
• Clinical laboratory results,
• Vital signs,
• Concomitant medications. Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods.

Enrollment: 6 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Single oral dose in healthy male volunteers

Experimental group

Description:

There will be only one group of participants that will receive a single oral capsule dose, administered under fed conditions following a standardized meal.

Treatment:

Drug: GEn-1124