HealthyPhase 1NCT06979973
A Drug-drug Interaction Study to Investigate the Pharmacokinetic Interactions Between CKD-508, Midazolam, and Rosuvastatin in Healthy Adult Male Participants
A Phase 1 study testing Midazolam, Rosuvastatin and CKD-508 Tablet in people with Healthy, run by Chong Kun Dang Pharmaceutical at 1 site in United States.
Trial summary
Phase 1, open-label, non-randomized, three-treatment, one-sequence interaction study to evaluate the PK interactions between CKD-508, midazolam, and rosuvastatin in healthy adult male participants Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Midazolam, Rosuvastatin and CKD-508 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to 17 Aug 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant is capable of providing signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.
- Male adults aged 18 to 45 years at screening.
- Healthy participants were determined by pre-study medical evaluation and judged by the Investigator.
- Non-smoker (or other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (<200 ng/mL) at screening and admission.
Who cannot join
- History or evidence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder as determined by the Investigator.
- Presence of any disorder that would interfere with the absorption, distribution, metabolism, or excretion of study intervention as judged by the Investigator.
- Serum alkaline phosphatase (ALP) or total bilirubin ≥upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >ULN at either screening or admission.
- Abnormal renal function with estimated glomerular filtration rate (eGFR) <80 mL/min/1.73 m2 at screening.
- History or presence of clinically significant abnormal cardiac automaticity, heart rhythm, ECG findings, or other relevant conditions that may pose a risk to the participants as judged by the Investigator.
- Resting heart rate ≥100 bpm or <50 bpm at screening or admission.
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- Resting systolic blood pressure ≥140 mmHg and /or diastolic blood pressure ≥90 mmHg at screening or admission.
- Evidence of known risk factors for atrial fibrillation (eg, smoking, hyperthyroidism, diabetes)
- History of alcohol and/or illicit drug abuse within 2 years before screening or positive urine test for alcohol or positive urine drug test at screening or admission.
- Positive test for HBsAg, HCV RNA, or HIV antibody at screening.
- Donation of blood (>500 mL) or blood products within 2 months prior to dosing.
- Use of over-the-counter medications (including vitamins), prescription medications, or herbal remedies within 14 days or 5 half-lives, whichever is longer, prior to dosing.
- Receiving an investigational drug within 30 days or >5 half-lives of the investigational drug, whichever is longer, prior to dosing.
- History of hypersensitivity to CETP inhibitor or statins or midazolam or to medicinal products with similar chemical structures.
- Individual unlikely to comply with the protocol requirements, instructions, and study-related restrictions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Drug-Drug Interaction Study to Assess the Pharmacokinetic Interactions Between CKD-508, Midazolam, and Rosuvastatin in Healthy Adult Male Participants
Phase 1, open-label, non-randomized, three-treatment, one-sequence interaction study to evaluate the PK interactions between CKD-508, midazolam, and rosuvastatin in healthy adult male participants
- Conditions
- Healthy
- Being tested
- Midazolam, Rosuvastatin, CKD-508 Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
midazolam syrup
RosuvastatinDrug
Rosuvastatin
CKD-508 TabletDrug
CKD-508
| Study group | Role | What they receive |
|---|---|---|
| Midazolam, Rosuvastatin, CKD-508 | Experimental | Single dose of Midazolam Single and Multiple dose of Rosuvastatin Multiple dose of CKD-508 Receives: Drug: Midazolam; Drug: Rosuvastatin; Drug: CKD-508 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of midazolam
Maximum plasma concentrations of midazolam after single dose
Measured: 24 hours
AUClast of midazolam
Area under the concentration-time curve of midazolam after single dose
Measured: 24 hours
AUCinf of midazolam
Area under the concentration-time curve extrapolated to infinity of midazolam
Measured: From 0 hours to 24 hours on Day 1 and Day 24
Cmax of Rosuvastatin
Maximum plasma concentrations of rosuvastatin after single dose
Measured: 72 hours
AUClast of rosuvastatin
Area under the concentration-time curve of rosuvastatin after single dose
Measured: 72 hours
AUCinf of rosuvastatin
Area under the concentration-time curve extrapolated to infinity of rosuvastatin
Measured: From 0 hours to 72 hours on Day 1 and Day 24
Cmax,ss of CKD-508
Maximum plasma concentration at steady state of CKD-508
Measured: 24 hours
AUCtau,ss of CKD-508
Area under the concentration time curve until the end of dosing interval at steady state of CKD-508
Measured: 24 hours
Cmin,ss of CKD-508
Minimum plasma concentration at steady state of CKD-508
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start14 May 2025
- Primary completion17 Aug 2025
- Study completion17 Aug 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT06979973
- Sponsor's protocol ID
- A104_03DDI2501
- Status last verified
- Feb 2026
- First submitted
- 9 May 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Drug-Drug Interaction Study to Assess the Pharmacokinetic Interactions Between CKD-508, Midazolam, and Rosuvastatin in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT06979973
- Acronym / sponsor ID
- A104_03DDI2501
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 14 May 2025 (actual)
- Primary completion
- 17 Aug 2025 (actual)
- Study completion
- 17 Aug 2025 (actual)
- First posted
- 20 May 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.
Phase 1, open-label, non-randomized, three-treatment, one-sequence interaction study to evaluate the PK interactions between CKD-508, midazolam, and rosuvastatin in healthy adult male participants
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midazolam, Rosuvastatin, CKD-508 | Experimental | Drug: Midazolam, Drug: Rosuvastatin, Drug: CKD-508 TabletSingle dose of Midazolam Single and Multiple dose of Rosuvastatin Multiple dose of CKD-508 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The participant is capable of providing signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.
- Male adults aged 18 to 45 years at screening.
- Healthy participants were determined by pre-study medical evaluation and judged by the Investigator.
- Non-smoker (or other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (<200 ng/mL) at screening and admission.
Key exclusion criteria (15 listed)
- History or evidence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder as determined by the Investigator.
- Presence of any disorder that would interfere with the absorption, distribution, metabolism, or excretion of study intervention as judged by the Investigator.
- Serum alkaline phosphatase (ALP) or total bilirubin ≥upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >ULN at either screening or admission.
- Abnormal renal function with estimated glomerular filtration rate (eGFR) <80 mL/min/1.73 m2 at screening.
- History or presence of clinically significant abnormal cardiac automaticity, heart rhythm, ECG findings, or other relevant conditions that may pose a risk to the participants as judged by the Investigator.
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 |
|---|---|---|
| Midazolammidazolam syrup | Drug | Midazolam, Rosuvastatin, CKD-508 |
| RosuvastatinRosuvastatin | Drug | Midazolam, Rosuvastatin, CKD-508 |
| CKD-508 TabletCKD-508 | Drug | Midazolam, Rosuvastatin, CKD-508 |
Primary outcome
Cmax of midazolam
Time frame: 24 hours
Maximum plasma concentrations of midazolam after single dose
AUClast of midazolam
Time frame: 24 hours
Area under the concentration-time curve of midazolam after single dose
AUCinf of midazolam
Time frame: From 0 hours to 24 hours on Day 1 and Day 24
Area under the concentration-time curve extrapolated to infinity of midazolam
Cmax of Rosuvastatin
Time frame: 72 hours
Maximum plasma concentrations of rosuvastatin after single dose
AUClast of rosuvastatin
Time frame: 72 hours
Area under the concentration-time curve of rosuvastatin after single dose
AUCinf of rosuvastatin
Time frame: From 0 hours to 72 hours on Day 1 and Day 24
Area under the concentration-time curve extrapolated to infinity of rosuvastatin
Cmax,ss of CKD-508
Time frame: 24 hours
Maximum plasma concentration at steady state of CKD-508
AUCtau,ss of CKD-508
Time frame: 24 hours
Area under the concentration time curve until the end of dosing interval at steady state of CKD-508
Cmin,ss of CKD-508
Time frame: 24 hours
Minimum plasma concentration at steady state of CKD-508
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 27 Feb 2026.
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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 Midazolam, Rosuvastatin and CKD-508 Tablet in people with Healthy, run by Chong Kun Dang Pharmaceutical at 1 site in United States.
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 15 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 27 Feb 2026. 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 United States. 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 midazolam (time frame: 24 hours). The study lists 9 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 27 Feb 2026.