Alzheimer's DiseasePhase 1NCT02695004
Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).
A Phase 1 study testing DKF-310 in people with Alzheimer's Disease, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- DKF-310
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2016to Mar 2017
- 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 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged 19 to 50 years
- Body weight 55 to 90 kg and BMI 18.0 to 27.0
- Voluntarily signed the informed consent form
- Eligible according to the screening test results
- Available to follow up after drop-out
Who cannot join
- Clinically significant disorders or a medical history of hepatic, renal, neurological, respiratory, endocrine, hemato-oncologic, cardiovascular, urological and psychiatric diseases
- Hypersensitivity to donepezil, piperidine derivatives and other drugs
- SBP <100 mmHg or >150 mmHg, or DBP <60 mmHg or >100 mmHg
- Skin and muscle disorders or history of surgery at the injection site
- AST or ALT >1.5xULN; QT/QTcB interval >450 ms
- History or positive result of drug abuse
Show all 13Show fewer
- Prescribed drugs or herbal medicines within 2 weeks, over-the-counter drugs or vitamins within 1 week
- Participated in other clinical trials within 3 months
- Donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month
- Alcohol consumption >21 units/week
- Smoked >10 cigarettes/day within 3 months
- Caffeine-containing foods
- Not eligible due to other reasons at the investigator's discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of DKF-310 Intramuscular Injection in Healthy Male Volunteers
This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy male volunteers.
- Conditions
- Alzheimer's Disease
- Being tested
- DKF-310, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKF-310Drug
Also called Donepezil
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Donepezil 35 mg | Experimental | Donepezil 35 mg or placebo Receives: Drug: DKF-310; Drug: Placebo |
| Donepezil 70 mg | Experimental | Donepezil 70 mg or placebo Receives: Drug: DKF-310; Drug: Placebo |
| Donepezil140 mg | Experimental | Donepezil 140 mg or placebo Receives: Drug: DKF-310; Drug: Placebo |
| Donepezil 210 mg | Experimental | Donepezil 210 mg or placebo Receives: Drug: DKF-310; Drug: Placebo |
| Donepezil 280 mg | Experimental | Donepezil 280 mg or placebo Receives: Drug: DKF-310; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h
Measured: 1056h
Cmax
0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h
Measured: 1056h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongkook Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695004
- Sponsor's protocol ID
- DKF-310-P1
- Status last verified
- Feb 2016
- First submitted
- 18 Feb 2016
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of DKF-310 Intramuscular Injection in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02695004
- Acronym / sponsor ID
- DKF-310-P1
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Dongkook Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 1 Mar 2016 (estimated)
- 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 is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy male volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Donepezil 35 mg | Experimental | Drug: DKF-310, Drug: PlaceboDonepezil 35 mg or placebo |
| Donepezil 70 mg | Experimental | Drug: DKF-310, Drug: PlaceboDonepezil 70 mg or placebo |
| Donepezil140 mg | Experimental | Drug: DKF-310, Drug: PlaceboDonepezil 140 mg or placebo |
| Donepezil 210 mg | Experimental | Drug: DKF-310, Drug: PlaceboDonepezil 210 mg or placebo |
| Donepezil 280 mg | Experimental | Drug: DKF-310, Drug: PlaceboDonepezil 280 mg or placebo |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men aged 19 to 50 years
- Body weight 55 to 90 kg and BMI 18.0 to 27.0
- Voluntarily signed the informed consent form
- Eligible according to the screening test results
- Available to follow up after drop-out
Key exclusion criteria (13 listed)
- Clinically significant disorders or a medical history of hepatic, renal, neurological, respiratory, endocrine, hemato-oncologic, cardiovascular, urological and psychiatric diseases
- Hypersensitivity to donepezil, piperidine derivatives and other drugs
- SBP <100 mmHg or >150 mmHg, or DBP <60 mmHg or >100 mmHg
- Skin and muscle disorders or history of surgery at the injection site
- AST or ALT >1.5xULN; QT/QTcB interval >450 ms
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 |
|---|---|---|
| DKF-310Also: Donepezil | Drug | Donepezil 210 mg, Donepezil 280 mg, Donepezil 35 mg, Donepezil 70 mg, Donepezil140 mg |
| Placebo | Drug | Donepezil 210 mg, Donepezil 280 mg, Donepezil 35 mg, Donepezil 70 mg, Donepezil140 mg |
Primary outcome
AUC
Time frame: 1056h
0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h
Cmax
Time frame: 1056h
0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h
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 6 Apr 2020.
- Individual participant dataSharing planned: No
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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 DKF-310 in people with Alzheimer's Disease, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 13 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 6 Apr 2020. 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 South Korea. 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. 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?
AUC (time frame: 1056h). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2020.