HealthyPhase 1NCT04304547
Clinical Study to Evauate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers
A Phase 1 study testing CKD-828, D097, D337, CKD-348 T1, CKD-348 T2, CKD-348 T1, CKD-348 T2, CKD-828, D097, D337, and CKD-348 T2, CKD-348 T1, CKD-828, D097, D337 in people with Healthy, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D097 and D337 in healthy adult volunteers Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CKD-828, D097, D337, CKD-348 T1, CKD-348 T2, CKD-348 T1, CKD-348 T2, CKD-828, D097, D337, and CKD-348 T2, CKD-348 T1, CKD-828, D097, D337
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Feb 2020to 2 Apr 2020
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19 ≤ age ≤ 45
- Health Volunteers
- Subject who agreeds to participate in this clinical trial voluntarily
Who cannot join
- 1. Subject who cannot participate in a clinical trial based on the PI's judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers
Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D097 and D337 in healthy adult volunteers
- Conditions
- Healthy
- Being tested
- CKD-828, D097, D337, CKD-348 T1, CKD-348 T2, CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,, CKD-348 T2, CKD-348 T1, CKD-828, D097, D337
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-828, D097, D337, CKD-348 T1, CKD-348 T2Drug
Also called Sequence A
Subject of sequence A takes IP in the following order:
- Each tablet of CKD-828 and D097 and D337 be taken at once
- CKD-348 T1 1 tablet
- CKD-348 T2 1 tabet
CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,Drug
Also called Sequence B
Subject of sequence B takes IP in the following order:
- CKD-348 T1 1 tablet
- CKD-348 T2 1 tablet
- Each tablet of CKD-828 and D097 and D337 be taken at once
CKD-348 T2, CKD-348 T1, CKD-828, D097, D337Drug
Also called Sequence C
Subject of sequence C takes IP in the following order:
- CKD-348 T2 1 tablet
- Each tablet of CKD-828 and D097 and D337 be taken at once
- CKD-348 T1 1 tablet
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Active comparator | CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 Receives: Drug: CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 |
| Sequence B | Active comparator | CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 Receives: Drug: CKD-348 T1, CKD-348 T2, CKD-828, D097, D337, |
| Sequence C | Active comparator | CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 Receives: Drug: CKD-348 T2, CKD-348 T1, CKD-828, D097, D337 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration of the drug
Measured: 0 hour ~ 144 hr
AUCt
Area under the concentration time curve from time zero to time
Measured: 0 hour ~ 144 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start4 Feb 2020
- Primary completion2 Apr 2020
- Study completion2 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Yong Chung, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304547
- Sponsor's protocol ID
- A86_04BE1913P
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 13 Aug 2020
- 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 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04304547
- Acronym / sponsor ID
- A86_04BE1913P
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 11 Mar 2020 (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.
Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D097 and D337 in healthy adult volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Active comparator | Drug: CKD-828, D097, D337, CKD-348 T1, CKD-348 T2CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 |
| Sequence B | Active comparator | Drug: CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 |
| Sequence C | Active comparator | Drug: CKD-348 T2, CKD-348 T1, CKD-828, D097, D337CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 19 ≤ age ≤ 45
- Health Volunteers
- Subject who agreeds to participate in this clinical trial voluntarily
Key exclusion criteria (1 listed)
- 1. Subject who cannot participate in a clinical trial based on the PI's judgment
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-828, D097, D337, CKD-348 T1, CKD-348 T2Also: Sequence ASubject of sequence A takes IP in the following order: 1. Each tablet of CKD-828 and D097 and D337 be taken at once 2. CKD-348 T1 1 tablet 3. CKD-348 T2 1 tabet | Drug | Sequence A |
| CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,Also: Sequence BSubject of sequence B takes IP in the following order: 1. CKD-348 T1 1 tablet 2. CKD-348 T2 1 tablet 3. Each tablet of CKD-828 and D097 and D337 be taken at once | Drug | Sequence B |
| CKD-348 T2, CKD-348 T1, CKD-828, D097, D337Also: Sequence CSubject of sequence C takes IP in the following order: 1. CKD-348 T2 1 tablet 2. Each tablet of CKD-828 and D097 and D337 be taken at once 3. CKD-348 T1 1 tablet | Drug | Sequence C |
Primary outcome
Cmax
Time frame: 0 hour ~ 144 hr
Maximum plasma concentration of the drug
AUCt
Time frame: 0 hour ~ 144 hour
Area under the concentration time curve from time zero to time
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 Aug 2020.
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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.
Jae Yong Chung principal investigator
Seoul National University Bundang Hospital
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-828, D097, D337, CKD-348 T1, CKD-348 T2, CKD-348 T1, CKD-348 T2, CKD-828, D097, D337, and CKD-348 T2, CKD-348 T1, CKD-828, D097, D337 in people with Healthy, 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 3 inclusion and 1 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 Aug 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?
Cmax (time frame: 0 hour ~ 144 hr). 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 13 Aug 2020.