Back to resultsDose-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
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
GB-5001
Placebo
Oral cohort
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
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.
Sites / Locations
- Syneos Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
GB-5001
Placebo
Oral cohort
Arm Description
GB-5001 Suspension for intramuscular (IM) injection at three doses
Placebo Suspension for intramuscular (IM) injection, Volume to be matched with the active drug in the respective cohort
Aricept® tablet
Outcomes
Primary Outcome Measures
Incidence, severity, and dose-relationship of AEs
Vital signs
blood pressure [BP], respiratory rate [RR], heart rate [HR], and temperature
Electrocardiograms
Physical examination
Height, weight, and BMI will be recorded
Injection site assessments
Secondary Outcome Measures
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
Key PK parameters for single dose IM and Oral cohorts
Cmax: maximum observed plasma concentration
Key PK parameters for single dose IM and Oral cohorts
tmax: time to maximum observed plasma concentration
Key PK parameters for single dose IM and Oral cohorts
λz: terminal elimination rate constant
Key PK parameters for single dose IM and Oral cohorts
t½: terminal elimination half-life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05525780
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 26, 2022 (Actual)
Primary Completion Date
June 2, 2023 (Actual)
Study Completion Date
June 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
G2GBio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GB-5001
Arm Type
Experimental
Arm Description
GB-5001 Suspension for intramuscular (IM) injection at three doses
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Suspension for intramuscular (IM) injection, Volume to be matched with the active drug in the respective cohort
Arm Title
Oral cohort
Arm Type
Active Comparator
Arm Description
Aricept® tablet
Intervention Type
Drug
Intervention Name(s)
GB-5001
Intervention Description
Depending on the cohort, volume will be varied to administer.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A matched volume of placebo product will be administered to each subject in each cohort.
Intervention Type
Drug
Intervention Name(s)
Oral cohort
Intervention Description
Single dose of Aricept tablet
Primary Outcome Measure Information:
Title
Incidence, severity, and dose-relationship of AEs
Time Frame
Day 64
Title
Vital signs
Description
blood pressure [BP], respiratory rate [RR], heart rate [HR], and temperature
Time Frame
Day 64
Title
Electrocardiograms
Time Frame
Day 64
Title
Physical examination
Description
Height, weight, and BMI will be recorded
Time Frame
Day 64
Title
Injection site assessments
Time Frame
Day 64
Secondary Outcome Measure Information:
Title
Key PK parameters for single dose IM and Oral cohorts
Description
AUCt: area under the plasma concentration vs time curve from time 0 to the time of the last measurable concentration
Time Frame
Day 64
Title
Key PK parameters for single dose IM and Oral cohorts
Description
Cmax: maximum observed plasma concentration
Time Frame
Day 64
Title
Key PK parameters for single dose IM and Oral cohorts
Description
tmax: time to maximum observed plasma concentration
Time Frame
Day 64
Title
Key PK parameters for single dose IM and Oral cohorts
Description
λz: terminal elimination rate constant
Time Frame
Day 64
Title
Key PK parameters for single dose IM and Oral cohorts
Description
t½: terminal elimination half-life
Time Frame
Day 64
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Syneos Health
City
Québec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
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
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