Alzheimer DiseasePhase 1NCT05525780
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
A Phase 1 study testing GB-5001 and Oral cohort in people with Alzheimer Disease, run by G2GBio, Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- GB-5001 and Oral cohort
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2022to 2 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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".
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Alzheimer Disease
- Being tested
- GB-5001, Placebo, Oral cohort
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB-5001Drug
Depending on the cohort, volume will be varied to administer.
PlaceboDrug
A matched volume of placebo product will be administered to each subject in each cohort.
Oral cohortDrug
Single dose of Aricept tablet
| Study group | Role | What they receive |
|---|---|---|
| GB-5001 | Experimental | GB-5001 Suspension for intramuscular (IM) injection at three doses Receives: Drug: GB-5001 |
| Placebo | Placebo comparator | Placebo Suspension for intramuscular (IM) injection, Volume to be matched with the active drug in the respective cohort Receives: Drug: Placebo |
| Oral cohort | Active comparator | Aricept® tablet Receives: Drug: Oral cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, and dose-relationship of AEs
Measured: Day 64
Vital signs
blood pressure [BP], respiratory rate [RR], heart rate [HR], and temperature
Measured: Day 64
Electrocardiograms
Measured: Day 64
Physical examination
Height, weight, and BMI will be recorded
Measured: Day 64
Injection site assessments
Measured: Day 64
Secondary outcomes (5)
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
Measured: Day 64
Key PK parameters for single dose IM and Oral cohorts
Cmax: maximum observed plasma concentration
Measured: Day 64
Key PK parameters for single dose IM and Oral cohorts
tmax: time to maximum observed plasma concentration
Measured: Day 64
Key PK parameters for single dose IM and Oral cohorts
λz: terminal elimination rate constant
Measured: Day 64
Key PK parameters for single dose IM and Oral cohorts
t½: terminal elimination half-life
Measured: Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start26 Aug 2022
- Primary completion2 Jun 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- G2GBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525780
- Sponsor's protocol ID
- G2GBio
- Status last verified
- Jul 2023
- First submitted
- 23 Aug 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khwarg J, Lee H, Yu KS, Seol E, Chung JY. Population Pharmacokinetic Modeling and Simulation for Dose Optimization of GB-5001, a Long-Acting Intramuscular Injection of Donepezil, in Healthy Participants. Neurol Ther. 2024 Oct;13(5):1453-1466. doi: 10.1007/s40120-024-00643-4. Epub 2024 Aug 10.
PubMed 39126603
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05525780
- Acronym / sponsor ID
- G2GBio
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- G2GBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GB-5001 | Experimental | Drug: GB-5001GB-5001 Suspension for intramuscular (IM) injection at three doses |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Suspension for intramuscular (IM) injection, Volume to be matched with the active drug in the respective cohort |
| Oral cohort | Active comparator | Drug: Oral cohortAricept® tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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".
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB-5001Depending on the cohort, volume will be varied to administer. | Drug | GB-5001 |
| PlaceboA matched volume of placebo product will be administered to each subject in each cohort. | Drug | Placebo |
| Oral cohortSingle dose of Aricept tablet | Drug | Oral cohort |
Primary outcome
Incidence, severity, and dose-relationship of AEs
Time frame: Day 64
Vital signs
Time frame: Day 64
blood pressure [BP], respiratory rate [RR], heart rate [HR], and temperature
Electrocardiograms
Time frame: Day 64
Physical examination
Time frame: Day 64
Height, weight, and BMI will be recorded
Injection site assessments
Time frame: Day 64
5 secondary outcomes
Key PK parameters for single dose IM and Oral cohorts
Time frame: Day 64
Key PK parameters for single dose IM and Oral cohorts
Time frame: Day 64
Key PK parameters for single dose IM and Oral cohorts
Time frame: Day 64
Key PK parameters for single dose IM and Oral cohorts
Time frame: Day 64
Key PK parameters for single dose IM and Oral cohorts
Time frame: Day 64
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Derived from this study: PubMed 39126603Khwarg J, Lee H, Yu KS, Seol E, Chung JY. Population Pharmacokinetic Modeling and Simulation for Dose Optimization of GB-5001, a Long-Acting Intramuscular Injection of Donepezil, in Healthy Participants. Neurol Ther. 2024 Oct;13(5):1453-1466. doi: 10.1007/s40120-024-00643-4. Epub 2024 Aug 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB-5001 and Oral cohort in people with Alzheimer Disease, run by G2GBio, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, and dose-relationship of AEs (time frame: Day 64). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05525780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.