Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 IM Depot and Aricept® Oral Tablets in Healthy Male Volunteers

Alzheimer Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 Intramuscular Depot and Aricept® Oral Tablets (Pfizer Canada Inc.) in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05525780
• Other study ID #: G2GBio
• Status: Completed
• Phase: Phase 1
• Start date: August 26, 2022
• Est. completion date: June 2, 2023

Study information

• Verified date: July 2023
• Source: G2GBio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil) IM depot in healthy male volunteers. And, it is to predict the multiple-dose pharmacokinetics based on the single-dose pharmacokinetics of GB-5001 IM depot and the oral Aricept® (donepezil hydrochloride) tablet by PK modeling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy, non-smoking male volunteers, 18-55 years of age, inclusive at the time of informed consent.

• Body mass index (BMI) that is within 18.5 - 30.0 kg/m2, inclusive, and weight at least 55 kg and above.

• Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.

• Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 60-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.

• Clinical laboratory values within the clinical site's most recent acceptable laboratory test range, and/or values are deemed by the PI/Sub-Investigator as "Not Clinically Significant".

Exclusion Criteria:

• Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.

• Known history or presence of seizure or convulsion, unless determined as not clinically significant by the PI/Sub-Investigator.

• Known history or presence of peptic ulcer or gastrointestinal bleeding within 3 months prior to study drug administration, unless determined as not clinically significant by the PI/Sub-Investigator.

• Known risk of developing ulcers (for example, if you are taking non-steroidal anti-inflammatory drugs [NSAIDS] or high doses of acetylsalicylic acid [ASA] [Aspirin®]), unless determined as not clinically significant by the PI/Sub-Investigator.

• Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug experienced within 7 days prior to study drug administration, as determined by the PI/Sub-Investigator.

• Presence of any clinically significant illness within 30 days prior to dosing, as determined by the PI/Sub-Investigator

• Presence of any clinically significant illness within 30 days prior to dosing, as determined by the PI/Sub-Investigator.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• GB-5001
Depending on the cohort, volume will be varied to administer.
• Placebo
A matched volume of placebo product will be administered to each subject in each cohort.
• Oral cohort
Single dose of Aricept tablet

Locations

Country	Name	City	State
Canada	Syneos Health	Québec

Sponsors (1)

Lead Sponsor	Collaborator
G2GBio, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, severity, and dose-relationship of AEs		Day 64
Primary	Vital signs	blood pressure [BP], respiratory rate [RR], heart rate [HR], and temperature	Day 64
Primary	Electrocardiograms		Day 64
Primary	Physical examination	Height, weight, and BMI will be recorded	Day 64
Primary	Injection site assessments		Day 64
Secondary	Key PK parameters for single dose IM and Oral cohorts	AUCt: area under the plasma concentration vs time curve from time 0 to the time of the last measurable concentration	Day 64
Secondary	Key PK parameters for single dose IM and Oral cohorts	Cmax: maximum observed plasma concentration	Day 64
Secondary	Key PK parameters for single dose IM and Oral cohorts	tmax: time to maximum observed plasma concentration	Day 64
Secondary	Key PK parameters for single dose IM and Oral cohorts	?z: terminal elimination rate constant	Day 64
Secondary	Key PK parameters for single dose IM and Oral cohorts	t½: terminal elimination half-life	Day 64