DyslipidemiaPhase 1NCT06758661
Clinical Study to Evaluate Drug-drug Interaction and Safety After Co-administration of D352 and D794 in Healthy Adult Volunteers
A Phase 1 study testing D352 and D794 in people with Dyslipidemia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is a randomized, open-label, single arm, multi-dose, crossover study to evaluate drug-drug interaction and safety after co-administration of D352 and D794 in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- D352 and D794
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Nov 2024to 3 Feb 2025
- 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 volunteers between the ages of 19 years to 55 years.
- Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) < 30 kg/m2 and total body weight ≥ 55 kg (woman total body weight ≥ 45 kg) BMI = Weight(kg)/ Height(m)2
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
- Individuals who were deemed to be appropriate as study subjects following vital sign, laboratory tests (hematology, blood chemistry, serology, urology etc.) etc. performed
- Individuals who agreed proper contraception during the study and did consent to not donation of sperm or eggs 14 days after the last dose of study drug
- Individuals who signed an informed consent form after being fully informed of the study prior to participation, including the objective, content, adverse events etc.
Who cannot join
- Individuals with a history of hypersensitivity to any of the major ingredients or components of the investigational product
- Individuals who have genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption
- Individuals who have a history of hypersensitivity or allergy to this ingredient because it contains Sunset Yellow FCF
- Patients with the following diseases
- Patients with active liver disease or persistently elevated aminotransferase levels of unknown cause
- Patients with severe hepatic impairment of biliary obstruction and patients with cholestasis
Show all 22Show fewer
- Patients receiving cyclosporine
- Myopathic patients
- Individuals with a history of gastrointestinal surgery or gastrointestinal disease that may affect drug absorption
- Individuals who exceed the following condition with 1 month of the first administration of investigational product
- Alcohol: Man-21 glasses/week, Woman-14 glasses/week (1 glass = soju 50mL or liquor 30mL or beer 250mL)
- Smoking: 20 cigarettes/day
- Individuals who cannot restrict the intake of grapefruit or food containing grapefruit from three days before the first administration of investigational product until the final pharmacokinetic blood sample is collected
- Individuals who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing administration
- Individuals who have taken any specialty or herbal medicine within 2 weeks prior to the first administration, or any over-the-counter(OTC) or dietary supplement or vitamin preparation, including liver function supplements, within 1 week prior to the first administration
- Individuals with a history of substance abuse or test positive for drugs of abuse on a urine screening test
- Individuals who had been administered investigational product from other clinical study within the 6 months prior to the first administration
- Individuals who donated whole blood within the 8 weeks, or blood components within 2 weeks or had a blood transfusion within 4 weeks prior to the first administration of investigational product
- Woman who are pregnant or breastfeeding
- Individuals who have difficulty abstaining from omega-3-containing foods(such as oily fish, chia seeds, flaxseeds, walnuts, etc.) from 7 days before the first administration until the end of study
- Individuals who determines that the tester is unfit to participate in the clinical trial in the final inclusion/exclusion criteria determined by combining the results of the clinical laboratory test conducted on the hospitalization date(-7D)
- Those who are deemed insufficient to participate in this clinical study by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-arm, Crossover, Multiple-dose Phase 1 Study to Evaluate Drug-drug Interaction and Safety After the Co-administration of D352 and D794, in Healthy Adult Volunteers
This study is a randomized, open-label, single arm, multi-dose, crossover study to evaluate drug-drug interaction and safety after co-administration of D352 and D794 in healthy adult volunteers.
Read the detailed description
36 healthy subjects are administration of D352 and D794 following each part. Pharmacokinetic blood samples are collected 1d to 22d. The drug-drug interaction and safety are assessed.
- Conditions
- Dyslipidemia
- Being tested
- D352, D794
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D352Drug
1 tablet
D794Drug
4 capsule
| Study group | Role | What they receive |
|---|---|---|
| D352-D352+D794(Part 1) | Experimental | Period 1: D352 1 tablet for 1 week, Period 2: D352 1 tablet and D794 4 capsule for 2 weeks Receives: Drug: D352; Drug: D794 |
| D794-D352+D794(Part 2) | Experimental | Period 1: D794 4 capsule for 2 weeks, Period 2: D352 1 tablet and D794 4 capsule for 1 week Receives: Drug: D352; Drug: D794 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau,ss of D352(Part 1)
Area under the D352 concentration in blood-time curve in steady-state
Measured: 1~7day 0 hour, 7day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour
AUCtau,ss of D794(Part 2)
Area under the D794 concentration in blood-time curve in steady-state
Measured: 1day -24 hour~-12 hour, 1~14day 0 hour, 14day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour
Cmax,ss of D352(Part 1)
The maximum D352 concentration in steady-state
Measured: 1~7day 0 hour, 7day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour
Cmax,ss of D794(Part 2)
The maximum D794 concentration in steady-state
Measured: 1day -24 hour~-12 hour, 1~14day 0 hour, 14day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start27 Nov 2024
- Primary completion24 Jan 2025
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06758661
- Sponsor's protocol ID
- A149_01DDI2409
- Status last verified
- May 2025
- First submitted
- 26 Dec 2024
- Last updated
- 21 May 2025
- 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Crossover, Multiple-dose Phase 1 Study to Evaluate Drug-drug Interaction and Safety After the Co-administration of D352 and D794, in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06758661
- Acronym / sponsor ID
- A149_01DDI2409
- Conditions
- Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 6 Jan 2025 (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.
This study is a randomized, open-label, single arm, multi-dose, crossover study to evaluate drug-drug interaction and safety after co-administration of D352 and D794 in healthy adult volunteers.
Detailed description
36 healthy subjects are administration of D352 and D794 following each part. Pharmacokinetic blood samples are collected 1d to 22d. The drug-drug interaction and safety are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D352-D352+D794(Part 1) | Experimental | Drug: D352, Drug: D794Period 1: D352 1 tablet for 1 week, Period 2: D352 1 tablet and D794 4 capsule for 2 weeks |
| D794-D352+D794(Part 2) | Experimental | Drug: D352, Drug: D794Period 1: D794 4 capsule for 2 weeks, Period 2: D352 1 tablet and D794 4 capsule for 1 week |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult volunteers between the ages of 19 years to 55 years.
- Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) < 30 kg/m2 and total body weight ≥ 55 kg (woman total body weight ≥ 45 kg) BMI = Weight(kg)/ Height(m)2
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
- Individuals who were deemed to be appropriate as study subjects following vital sign, laboratory tests (hematology, blood chemistry, serology, urology etc.) etc. performed
- Individuals who agreed proper contraception during the study and did consent to not donation of sperm or eggs 14 days after the last dose of study drug
Key exclusion criteria (22 listed)
- Individuals with a history of hypersensitivity to any of the major ingredients or components of the investigational product
- Individuals who have genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption
- Individuals who have a history of hypersensitivity or allergy to this ingredient because it contains Sunset Yellow FCF
- Patients with the following diseases
- Individuals with a history of gastrointestinal surgery or gastrointestinal disease that may affect drug absorption
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 |
|---|---|---|
| D3521 tablet | Drug | D352-D352+D794(Part 1), D794-D352+D794(Part 2) |
| D7944 capsule | Drug | D352-D352+D794(Part 1), D794-D352+D794(Part 2) |
Primary outcome
AUCtau,ss of D352(Part 1)
Time frame: 1~7day 0 hour, 7day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour
Area under the D352 concentration in blood-time curve in steady-state
AUCtau,ss of D794(Part 2)
Time frame: 1day -24 hour~-12 hour, 1~14day 0 hour, 14day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour
Area under the D794 concentration in blood-time curve in steady-state
Cmax,ss of D352(Part 1)
Time frame: 1~7day 0 hour, 7day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour
The maximum D352 concentration in steady-state
Cmax,ss of D794(Part 2)
Time frame: 1day -24 hour~-12 hour, 1~14day 0 hour, 14day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour
The maximum D794 concentration in steady-state
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 21 May 2025.
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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 D352 and D794 in people with Dyslipidemia, 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 6 inclusion and 22 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 21 May 2025. 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,ss of D352(Part 1) (time frame: 1~7day 0 hour, 7day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour). 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 21 May 2025.