Alzheimer's Disease (AD)Phase 1NCT03802162
A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355
A Phase 1 study testing CKD-355A (D797/Memantine HCl 20mg), CKD-355B (D797/Memantine HCl 20mg) and D797 in people with Alzheimer's Disease (AD), run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-355. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease (AD)
- What is being tested?
- CKD-355A (D797/Memantine HCl 20mg), CKD-355B (D797/Memantine HCl 20mg) and D797
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2019to 31 Aug 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult older than 19 years and less than 55 years at the time of screening
- BMI 18.5~29.9 kg/m2 and body weight more than 50kg
- Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to two months after the last investigational product and not to provide sperm for men
- Subjects who sign on an informed consent form willingly
Who cannot join
- Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease.
- Subjects who have acute disease within 28 days prior to the first administration
- Subjects who have history that may affect the ADME
- Subjects who have clinically significant chronic disease
- Women who are nursing, pregnant or positive on pregnancy test
- Subjects who have clinically significant allergic diseases
Show all 20Show fewer
- Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subjects who are known to be hypersensitive to the drug or its components
- Subjects who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody)
- Subjects with creatinine clearance <60 ml / min
- Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range
- Subjects who taked ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 1 week prior to the first administration
- Subjects who can not eat standard meals provided by the institution.
- Subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days
- Subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration
- Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days before the first administration (eg, ingestion of grapefruit juice>1 L / day)
- Subjects who participate in the other clinical trial within 90 days prior to the first administration
- Subjects who have a history of regular alcohol(alcohol>210g/week) or caffeine(caffeine>5 cups/day)
- Subjects who smokes more than 10 cigarettes per day within 3 months or cannot discontinue smoking during the clinical trial
- Subjects who is determined unsuitable to participate in this clinical trial by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Multiple-dosing Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355 With D797 and D324 in Healthy Subjects
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-355.
Read the detailed description
An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics, safety and tolerability of CKD-355 with D797 and D324 in healthy subjects
- Conditions
- Alzheimer's Disease (AD)
- Being tested
- CKD-355A (D797/Memantine HCl 20mg), CKD-355B (D797/Memantine HCl 20mg), D797, D324 (Memantine HCl 10mg)
- Keywords
- Alzheimer's disease, CKD-355
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-355A (D797/Memantine HCl 20mg)Drug
once a day
CKD-355B (D797/Memantine HCl 20mg)Drug
once a day
D797Drug
once a day
D324 (Memantine HCl 10mg)Drug
twice a day
| Study group | Role | What they receive |
|---|---|---|
| CKD-355A | Experimental | Not described Receives: Drug: CKD-355A (D797/Memantine HCl 20mg) |
| CKD-355B | Experimental | Not described Receives: Drug: CKD-355B (D797/Memantine HCl 20mg) |
| D797, D324 | Active comparator | Not described Receives: Drug: D797; Drug: D324 (Memantine HCl 10mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of D324
Max Concentration of D324
Measured: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
AUCt of D324
Area under the curve of D324
Measured: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Cmax of D797
Max Concentration of D797
Measured: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
AUCt of D797
Area under the curve of D797
Measured: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Secondary outcomes (6)
Cmin of D324
Min Concentration of D324
Measured: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Cmin of D797
Min Concentration of D797
Measured: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Tmax of D324
Time of Max concentration of D324
Measured: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Tmax of D797
Time of Max concentration of D797
Measured: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
t½ of D324
Half-life time of D324
Measured: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
t½ of D797
Half-life time of D797
Measured: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start15 Feb 2019
- Primary completion10 May 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802162
- Sponsor's protocol ID
- 179BE18029
- Status last verified
- Oct 2019
- First submitted
- 10 Jan 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multiple-dosing Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355 With D797 and D324 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03802162
- Acronym / sponsor ID
- 179BE18029
- Conditions
- Alzheimer's Disease (AD)
- Keywords
- Alzheimer's disease, CKD-355
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 14 Jan 2019 (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.
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-355.
Detailed description
An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics, safety and tolerability of CKD-355 with D797 and D324 in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD-355A | Experimental | Drug: CKD-355A (D797/Memantine HCl 20mg) |
| CKD-355B | Experimental | Drug: CKD-355B (D797/Memantine HCl 20mg) |
| D797, D324 | Active comparator | Drug: D797, Drug: D324 (Memantine HCl 10mg) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult older than 19 years and less than 55 years at the time of screening
- BMI 18.5~29.9 kg/m2 and body weight more than 50kg
- Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to two months after the last investigational product and not to provide sperm for men
- Subjects who sign on an informed consent form willingly
Key exclusion criteria (20 listed)
- Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease.
- Subjects who have acute disease within 28 days prior to the first administration
- Subjects who have history that may affect the ADME
- Subjects who have clinically significant chronic disease
- Women who are nursing, pregnant or positive on pregnancy test
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 |
|---|---|---|
| CKD-355A (D797/Memantine HCl 20mg)once a day | Drug | CKD-355A |
| CKD-355B (D797/Memantine HCl 20mg)once a day | Drug | CKD-355B |
| D797once a day | Drug | D797, D324 |
| D324 (Memantine HCl 10mg)twice a day | Drug | D797, D324 |
Primary outcome
Cmax of D324
Time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Max Concentration of D324
AUCt of D324
Time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Area under the curve of D324
Cmax of D797
Time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Max Concentration of D797
AUCt of D797
Time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Area under the curve of D797
6 secondary outcomes
Cmin of D324
Time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Cmin of D797
Time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Tmax of D324
Time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Tmax of D797
Time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
t½ of D324
Time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
t½ of D797
Time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
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 23 Oct 2019.
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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 CKD-355A (D797/Memantine HCl 20mg), CKD-355B (D797/Memantine HCl 20mg) and D797 in people with Alzheimer's Disease (AD), run by Chong Kun Dang Pharmaceutical 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 4 inclusion and 20 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 23 Oct 2019. 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?
Cmax of D324 (time frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours). The study lists 4 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 23 Oct 2019.