DyslipidemiasPhase 1NCT03726866
A Study to Investigate Drug-Drug Interaction Between D326, D337 and CKD-828 in Healthy Subjects
A Phase 1 study testing Sequence 1, Sequence 2 and Sequence 3 in people with Dyslipidemias and Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
To evaluate pharmacokinetic properties and drug interactions between D326 and D337 co-administered groups, the CKD-828 alone and the total co-administered groups. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Hypertension
- What is being tested?
- Sequence 1, Sequence 2 and Sequence 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Aug 2018to 15 Jan 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged between ≥ 19 and ≤ 40 years old
- Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m²
- Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial
- Subject who agree not to provide sperm
- Subject who voluntarily agree to participate in this study
Who cannot join
- Any medical history that may affect drug absorption, distribution, metabolism and excretion
- Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease.
- Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- Subject who have received other clinical trial drugs within 90 days prior to the screening visit
- Any clinically significant active chronic disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center, University of Ulsan
Seoul, 05505
About this study
Official title: A Randomized, Open Label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and Safety Among D326, D337 and CKD-828 in Healthy Subjects
To evaluate pharmacokinetic properties and drug interactions between D326 and D337 co-administered groups, the CKD-828 alone and the total co-administered groups.
- Conditions
- Dyslipidemias, Hypertension
- Being tested
- Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5
- Keywords
- dyslipidemias, hypertension, Drug-Drug interaction
- Medical subject headings
- Dyslipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequence 1Drug
D326, D337 or CKD-828 for 9 days
Sequence 2Drug
D326, D337 or CKD-828 for 9 days
Sequence 3Drug
D326, D337 or CKD-828 for 9 days
Sequence 4Drug
D326, D337 or CKD-828 for 9 days
Sequence 5Drug
D326, D337 or CKD-828 for 9 days
Sequence 6Drug
D326, D337 or CKD-828 for 9 days
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Sequence 1 Receives: Drug: Sequence 1 |
| Sequence 2 | Experimental | Sequence 2 Receives: Drug: Sequence 2 |
| Sequence 3 | Experimental | Sequence 3 Receives: Drug: Sequence 3 |
| Sequence 4 | Experimental | Sequence 4 Receives: Drug: Sequence 4 |
| Sequence 5 | Experimental | Sequence 5 Receives: Drug: Sequence 5 |
| Sequence 6 | Experimental | Sequence 6 Receives: Drug: Sequence 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax(Maximum plasma concentration of the drug at steady state)
PK parameters of D326, D337 and CKD-828
Measured: at Day 9
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
PK parameters of D326, D337 and CKD-828
Measured: at Day 9
Secondary outcomes (2)
Tmax(Time to maximum plasma concentration at steady state)
PK parameters of D326, D337 and CKD-828
Measured: at Day 9
t1/2(Terminal elimination half-life)
PK parameters of D326, D337 and CKD-828
Measured: at Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start31 Aug 2018
- Primary completion15 Jan 2019 (estimated)
- Study completion15 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyeong-Seok Lim, M.D., Ph.D., Principal investigator, Department of Clinical Pharmacology and Therapeutics / Asan Medical Center, University of Ulsan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726866
- Sponsor's protocol ID
- 186DDI18020
- Status last verified
- Oct 2018
- First submitted
- 30 Oct 2018
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and Safety Among D326, D337 and CKD-828 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03726866
- Acronym / sponsor ID
- 186DDI18020
- Conditions
- Dyslipidemias, Hypertension
- Keywords
- dyslipidemias, hypertension, Drug-Drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 15 Jan 2019 (estimated)
- Study completion
- 15 Jan 2019 (estimated)
- First posted
- 1 Nov 2018 (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.
To evaluate pharmacokinetic properties and drug interactions between D326 and D337 co-administered groups, the CKD-828 alone and the total co-administered groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Sequence 1Sequence 1 |
| Sequence 2 | Experimental | Drug: Sequence 2Sequence 2 |
| Sequence 3 | Experimental | Drug: Sequence 3Sequence 3 |
| Sequence 4 | Experimental | Drug: Sequence 4Sequence 4 |
| Sequence 5 | Experimental | Drug: Sequence 5Sequence 5 |
| Sequence 6 | Experimental | Drug: Sequence 6Sequence 6 |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers aged between ≥ 19 and ≤ 40 years old
- Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m²
- Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial
- Subject who agree not to provide sperm
- Subject who voluntarily agree to participate in this study
Key exclusion criteria (5 listed)
- Any medical history that may affect drug absorption, distribution, metabolism and excretion
- Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease.
- Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- Subject who have received other clinical trial drugs within 90 days prior to the screening visit
- Any clinically significant active chronic disease
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 |
|---|---|---|
| Sequence 1D326, D337 or CKD-828 for 9 days | Drug | Sequence 1 |
| Sequence 2D326, D337 or CKD-828 for 9 days | Drug | Sequence 2 |
| Sequence 3D326, D337 or CKD-828 for 9 days | Drug | Sequence 3 |
| Sequence 4D326, D337 or CKD-828 for 9 days | Drug | Sequence 4 |
| Sequence 5D326, D337 or CKD-828 for 9 days | Drug | Sequence 5 |
| Sequence 6D326, D337 or CKD-828 for 9 days | Drug | Sequence 6 |
Primary outcome
Cmax(Maximum plasma concentration of the drug at steady state)
Time frame: at Day 9
PK parameters of D326, D337 and CKD-828
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
Time frame: at Day 9
PK parameters of D326, D337 and CKD-828
2 secondary outcomes
Tmax(Time to maximum plasma concentration at steady state)
Time frame: at Day 9
t1/2(Terminal elimination half-life)
Time frame: at Day 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- 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.
Hyeong-Seok Lim, M.D., Ph.D. principal investigator
Department of Clinical Pharmacology and Therapeutics / Asan Medical Center, University of Ulsan
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 Sequence 1, Sequence 2 and Sequence 3 in people with Dyslipidemias and Hypertension, 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jihwan Oh (82-2-6373-0953, jihwan@ckdpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax(Maximum plasma concentration of the drug at steady state) (time frame: at Day 9). 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 1 Nov 2018.