DyslipidemiasPhase 1NCT03609606
A Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects
A Phase 1 study testing D013, D326 and D337, D013 and D326 and D337 in people with Dyslipidemias and Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Hypertension
- What is being tested?
- D013, D326 and D337, D013 and D326 and D337
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Aug 2018to 27 Sep 2018
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged between ≥ 20 and ≤ 45 years old
- Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
- Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm
- Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study
Who cannot join
- History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
- With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
- Any medical history that may affect drug absorption, distribution, metabolism and excretion
- Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- Any clinically significant active chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Multiple-dose Crossover Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects
A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
Read the detailed description
An open-label, randomized, multiple-dose crossover study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
- Conditions
- Dyslipidemias, Hypertension
- Being tested
- D013, D326 and D337, D013, D326 and D337
- Keywords
- Dyslipidemia, Hypertension, CKD-386, 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.
D013, D326 and D337Drug
Also called CKD-386 Test
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
D013Drug
Also called CKD-386 Reference1
Daily oral administration of 1 tablet under fasting conditions for 7 days
D326 and D337Drug
Also called CKD-386 Reference2
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Part A, Sequence1 | Experimental | * Period 1: Treatment of D013, D326 and D337 on Day1~Day7
* Period 2: Treatment of D013 on Day22~Day28 Receives: Drug: D013, D326 and D337; Drug: D013 |
| Part A, Sequence 2 | Experimental | * Period 1: Treatment of D013 on Day1~Day7
* Period 2: Treatment of D013, D326 and D337 on Day22~Day28 Receives: Drug: D013, D326 and D337; Drug: D013 |
| Part B, Sequence 1 | Experimental | * Period 1: Treatment of D013, D326 and D337 on Day1~Day7
* Period 2: Treatment of D326 and D337 on Day22~Day28 Receives: Drug: D013, D326 and D337; Drug: D326 and D337 |
| Part B, Sequence 2 | Experimental | * Period 1: Treatment of D326 and D337 on Day1~Day7
* Period 2: Treatment of D013, D326 and D337 on Day22~Day28 Receives: Drug: D013, D326 and D337; Drug: D326 and D337 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
- Part A: Pharmacokinetic parameter of D013 after multiple dosing
- Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Measured: 0(predose)~24 hours at Day7 and Day28
Cmax,ss(Maximum plasma concentration of the drug at steady state)
- Part A: Pharmacokinetic parameter of D013 after multiple dosing
- Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Measured: 0(predose)~24 hours at Day7 and Day28
Secondary outcomes (6)
Cmin,ss(Minimum concentration of the drug in plasma at steady state)
- Part A: Pharmacokinetic parameter of D013 after multiple dosing
- Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Measured: 0(predose)~24 hours at Day7 and Day28
Tmax,ss(Time to maximum plasma concentration at steady state)
- Part A: Pharmacokinetic parameter of D013 after multiple dosing
- Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Measured: 0(predose)~24 hours at Day7 and Day28
t1/2(Terminal elimination half-life)
- Part A: Pharmacokinetic parameter of D013 after multiple dosing
- Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Measured: 0(predose)~24 hours at Day7 and Day28
CLss/F(Apparent total body clearance of the drug from plasma at steady state)
- Part A: Pharmacokinetic parameter of D013 after multiple dosing
- Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Measured: 0(predose)~24 hours at Day7 and Day28
Vd,ss/F(Apparent volume of distribution at steady state)
- Part A: Pharmacokinetic parameter of D013 after multiple dosing
- Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Measured: 0(predose)~24 hours at Day7 and Day28
PTF(Peak-to-trough fluctuation)
- Part A: Pharmacokinetic parameter of D013 after multiple dosing
- Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Measured: 0(predose)~24 hours at Day7 and Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start9 Aug 2018
- Primary completion14 Sep 2018
- Study completion27 Sep 2018
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.
- 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ji-Young Park, M.D., Ph.D, Principal investigator, Department of Pharmacology, College of Medicine/ Department of Clinical Pharmacology&Toxicology, Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609606
- Sponsor's protocol ID
- 183DDI18011
- Status last verified
- Oct 2018
- First submitted
- 25 Jul 2018
- Last updated
- 5 Oct 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 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multiple-dose Crossover Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03609606
- Acronym / sponsor ID
- 183DDI18011
- Conditions
- Dyslipidemias, Hypertension
- Keywords
- Dyslipidemia, Hypertension, CKD-386, Drug-Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 1 Aug 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.
A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
Detailed description
An open-label, randomized, multiple-dose crossover study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A, Sequence1 | Experimental | Drug: D013, D326 and D337, Drug: D013* Period 1: Treatment of D013, D326 and D337 on Day1~Day7 * Period 2: Treatment of D013 on Day22~Day28 |
| Part A, Sequence 2 | Experimental | Drug: D013, D326 and D337, Drug: D013* Period 1: Treatment of D013 on Day1~Day7 * Period 2: Treatment of D013, D326 and D337 on Day22~Day28 |
| Part B, Sequence 1 | Experimental | Drug: D013, D326 and D337, Drug: D326 and D337* Period 1: Treatment of D013, D326 and D337 on Day1~Day7 * Period 2: Treatment of D326 and D337 on Day22~Day28 |
| Part B, Sequence 2 | Experimental | Drug: D013, D326 and D337, Drug: D326 and D337* Period 1: Treatment of D326 and D337 on Day1~Day7 * Period 2: Treatment of D013, D326 and D337 on Day22~Day28 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers aged between ≥ 20 and ≤ 45 years old
- Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
- Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm
- Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study
Key exclusion criteria (5 listed)
- History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
- With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
- Any medical history that may affect drug absorption, distribution, metabolism and excretion
- Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- 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 |
|---|---|---|
| D013, D326 and D337Also: CKD-386 TestDaily oral administration of 1 tablet for each drug under fasting conditions for 7 days | Drug | Part A, Sequence 2, Part A, Sequence1, Part B, Sequence 1, Part B, Sequence 2 |
| D013Also: CKD-386 Reference1Daily oral administration of 1 tablet under fasting conditions for 7 days | Drug | Part A, Sequence 2, Part A, Sequence1 |
| D326 and D337Also: CKD-386 Reference2Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days | Drug | Part B, Sequence 1, Part B, Sequence 2 |
Primary outcome
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
Time frame: 0(predose)~24 hours at Day7 and Day28
* Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Cmax,ss(Maximum plasma concentration of the drug at steady state)
Time frame: 0(predose)~24 hours at Day7 and Day28
* Part A: Pharmacokinetic parameter of D013 after multiple dosing * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
6 secondary outcomes
Cmin,ss(Minimum concentration of the drug in plasma at steady state)
Time frame: 0(predose)~24 hours at Day7 and Day28
Tmax,ss(Time to maximum plasma concentration at steady state)
Time frame: 0(predose)~24 hours at Day7 and Day28
t1/2(Terminal elimination half-life)
Time frame: 0(predose)~24 hours at Day7 and Day28
CLss/F(Apparent total body clearance of the drug from plasma at steady state)
Time frame: 0(predose)~24 hours at Day7 and Day28
Vd,ss/F(Apparent volume of distribution at steady state)
Time frame: 0(predose)~24 hours at Day7 and Day28
PTF(Peak-to-trough fluctuation)
Time frame: 0(predose)~24 hours at Day7 and Day28
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 5 Oct 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.
Ji-Young Park, M.D., Ph.D principal investigator
Department of Pharmacology, College of Medicine/ Department of Clinical Pharmacology&Toxicology, Anam 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 D013, D326 and D337, D013 and D326 and D337 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 4 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: finished, as of the sponsor's last update on 5 Oct 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?
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?
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state) (time frame: 0(predose)~24 hours at Day7 and Day28). 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 5 Oct 2018.