Evaluating safety and pharmacokinetics of donepezil injections in healthy men
An Open-label, Active-controlled, Parallel and Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intramuscular (IM) and Subcutaneous (SC) Donepezil (GB-5001) Injections Versus Donepezil Oral Tablet (Aricept®) in Healthy Male Volunteers
This study is testing if donepezil injections are safe and how they work in healthy men compared to taking the medication by mouth.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 19 Years to 55 Years |
| Sex | Male |
| Sponsor | G2GBio, Inc. Industry-sponsored |
| Locations | 1 site (Daejeon) |
| Trial ID | NCT06127368 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety, tolerability, and pharmacokinetics of a single dose of GB-5001 (donepezil) administered via intramuscular and subcutaneous injections compared to the oral form of donepezil in healthy male volunteers. The trial aims to determine how well these different administration routes work and their effects on the body. Healthy adult males aged 19 to 55 will be recruited, and their responses will be monitored to ensure safety and effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adult males aged 19 to 55 with a body weight of at least 55 kg and a BMI between 18.5 and 30.
Not a fit: Patients with chronic or congenital conditions, or those with a history of significant medical issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved administration methods for donepezil, potentially enhancing treatment options for Alzheimer's disease.
How similar studies have performed: While this approach is novel in the context of donepezil, similar studies evaluating alternative administration routes for other medications have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy adult males,19 to 55 years of age, inclusive at the time of screening visit * Subject with a body weight of 55 kg or more and a body mass index (BMI) equal to or greater than 18.5 kg/m² but less than 30 kg/m² * Subject without congenital or chronic conditions, and with no pathological symptoms or findings on internal medical examination * Subject who has been deemed suitable based on screening test results assessed by the principal investigator * Subject who can understand this clinical trial, provide informed written consent prior to the clinical trial procedures Exclusion Criteria: * Subjects with the following medical history or symptoms, as determined by the Principal Investigator to pose a risk to the trial. * Renal/Genitourinary, Gastrointestinal, Cardiovascular, Cerebrovascular, Pulmonary, Endocrine, Immune, Musculoskeletal, Neurological, Psychiatric, Dermatological, and Hematological conditions. * Rhabdomyolysis * Seizure, Epilepsy, Fainting * peptic ulcer or gastrointestinal hemorrhage * Gastrointestinal pathology, uncontrollable gastrointestinal symptoms or a history of disturbing absorption, distribution, metabolism or excretion * Severe physical/organ abnormalities * Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus * Subjects with a history of, or currently receiving, the following medications, as determined by the Principal Investigator regarded as a risk to the trial. * Medications, including antidepressants, that can induce Rhabdomyolysis * Medications with a risk of ulcer development. * Potent inhibitors of cytochrome P450 (CYP) enzymes * Anticholinergic drugs, cholinomimetics, and other cholinesterase inhibitors * Subjects who have difficulty with venipuncture or injection procedures via catheter or intravenous access * Subjects who have been consistently engaging in excessive smoking or consuming caffeine or alcohol within the last 3 months prior to screening, or Subjects who cannot abstain from smoking, caffeine, and alcohol consumption for at least 2 days before the scheduled administration of the investigational product or during the inpatient period
Where this trial is running
Daejeon
- Chungnam National University Hospital — Daejeon, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Jimin Hwang
- Email: clinicalstudy@g2gbio.com
- Phone: 82-2-400-2681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.