Healthy Adult Male
Conditions
Keywords
GEn-1124, Healthy Volunteer
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 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
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 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.
Interventions
DRUGGEn-1124
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.
Sponsors
GEn1E Lifesciences
InClin, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoints - Clinically significant changes to clinical lab results | From informed consent/screening visit to Day 2 | The incidence of adverse events based on the results of Clinical laboratory results, measured at screening, pre-dose and Day 2. Clinical labs to include chemistry, haematology, coagulation, and urinalysis. Results will be reviewed for any abnormalities and clinical significance. |
| Safety Endpoints - Clinically significant changes to vital signs | From informed consent/screening visit to Day 2 | The incidence of adverse events based on the results of Vital signs, measured at screening, pre-dose and Day 2. This includes systolic/diastolic blood pressure (mmHg ), heart rate (beats per minute), temperature (◦C), and oxygen saturation (SpO2) via pulse oximetry). Results will be reviewed for any abnormalities and clinical significance. |
| Safety Endpoints - Changes to concomitant medications | From 14 days (or 5 half-lives, whichever is longer) prior to Screening through completion of the study. | Changes in baseline concomitant medications recorded from 14 days (or 5 half-lives, whichever is longer) prior to Screening through completion of the study. |
| PK Endpoints - Plasma levels | From enrollment to Day 2 discharge | Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods, including: • Peak concentration (Cmax) |
| Safety Endpoints - Clinically significant changes to physical exam | From informed consent/screening visit to Day 2 | The incidence of adverse events related to changes to Complete Physical exam at screening and pre-dose. All other exams will be symptom-driven and performed at the very least on Day 2. Results will be reviewed for any abnormalities and clinical significance. |
| Safety Endpoints - Clinically significant changes to ECG results | From informed consent/screening visit to Day 2 | The incidence of adverse related to Electrocardiography (ECG) results, measured by the change from baseline ECG parameters at screening, pre-dose and Day 2. The following parameters will be reviewed: heart rate, QT interval, PR interval, QRS interval, and QT corrected interval (QTcF \[Fredericia's\]). All will be assessed as within normal limits, abnormal but not clinically significant, or abnormal and clinically significant on an ongoing basis. Comparison will be made by changes from baseline screening results. |
Countries
New Zealand
Outcome results
None listed