CKD-508 + Midazolam + Rosuvastatin for Healthy Subjects

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Chong Kun Dang Pharmaceutical

Must not be taking: Over-the-counter, Prescription, Herbal remedies

Disqualifiers: Cardiovascular, Renal, Hepatic, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine the interaction of three drugs—CKD-508, midazolam, and rosuvastatin—in healthy male adults. CKD-508 is the primary focus, and researchers seek to understand its effects when combined with the other two medications. Healthy, non-smoking men who have not used nicotine for six months are suitable candidates for this trial. Participants should not have any major health issues that could affect drug metabolism. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any over-the-counter medications, prescription medications, or herbal remedies at least 14 days before the trial starts.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CKD-508, a treatment under testing, has undergone previous safety studies. These studies primarily involved healthy individuals. Results indicate that the treatment is generally well-tolerated, with no major safety issues reported so far.

CKD-508 is not yet approved for any condition, so current information mainly comes from early human trials. These trials aim to ensure the treatment does not cause harm. To date, no serious side effects have been reported in healthy participants, suggesting that CKD-508 appears safe for further testing.

This information is based on early trials with healthy individuals. Always consult healthcare professionals when considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about CKD-508 because it offers a novel approach to drug metabolism and interaction studies, particularly in combination with Midazolam and Rosuvastatin. Unlike most treatments that focus solely on therapeutic outcomes, CKD-508 is being studied for its potential to enhance the metabolic processing and effectiveness of other drugs, which could lead to more efficient treatments with fewer side effects. This trial is particularly interesting because it explores how CKD-508 may influence the action and breakdown of common medications, potentially paving the way for more personalized and effective drug regimens.

What evidence suggests that this trial's treatments could be effective?

Researchers are currently studying CKD-508, focusing on its safety and how it works in the body. This trial tests CKD-508 alongside two other drugs, midazolam and rosuvastatin, to observe their interactions in healthy individuals. While specific information on CKD-508's effectiveness is not yet available, the study primarily aims to understand its absorption and potential side effects. These early studies focus more on the drug's absorption and tolerance rather than its effectiveness in treating a specific condition. As testing is still in the early stages, further research is needed to determine its potential benefits. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adult men who can safely take the medications involved. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Healthy participants determined by pre-study medical evaluation and judged by the Investigator

I am a man aged between 18 and 45.

I can sign and follow the study's consent form and rules.

Exclusion Criteria

I don't have any major health issues as decided by my doctor.

I don't have conditions that affect how my body handles medications.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive single and multiple doses of Midazolam, Rosuvastatin, and CKD-508 to evaluate pharmacokinetic interactions

4 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CKD-508

Trial Overview The study is testing how CKD-508 interacts with midazolam and rosuvastatin in the body. It's a Phase 1 trial where each participant will receive all three treatments in a specific order to see how they affect each other.

How Is the Trial Designed?

Group I: Midazolam, Rosuvastatin, CKD-508 Experimental Treatment 3 Interventions

Single dose of Midazolam Single and Multiple dose of Rosuvastatin Multiple dose of CKD-508

Who Is Running the Clinical Trial?

Chong Kun Dang Pharmaceutical

Lead Sponsor

Trials

292

Recruited

66,500+

Founded

1941

Headquarters

Seoul, South Korea

Known For

Biotechnology innovations

Top Products

Duvie, Camtobel, Belloxa, Gemtan

Young-Joo Kim

Chong Kun Dang Pharmaceutical

Chief Medical Officer since 2021

MD

Choi Hee-nam

Chong Kun Dang Pharmaceutical

Chief Executive Officer since 2024

Economics at Hanyang University; PhD in Economics, University of Pittsburgh

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06979973

Study Details | NCT06979973 | A Drug-drug Interaction ... ... CKD-508, Midazolam, and Rosuvastatin in Healthy Adult Male Participants. ClinicalTrials.gov ID NCT06979973. Sponsor Chong Kun Dang Pharmaceutical. Information ...

2. withpower.com withpower.com/trial/ckd-508-in-healthy-volunteers-21d9e

CKD-508 in Healthy Volunteers This Phase 1, randomized, parallel-group, placebo-controlled, double-blinded study aims to evaluate the safety, PK, and PD of CKD-508 when administered multiple ...

3. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/a-sad-mad-fe-safety-pk-pd-study-of-ckd-508-in-healthy-subjects/

A SAD, MAD, FE, Safety, PK & PD study of CKD-508 in ... This is a first-in-human clinical trial. The main purpose of the study is to see how safe CKD-508 is and how well the body tolerates CKD-508 after single and ...

4. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-4-2025-7b693

CKD-508 + Midazolam + Rosuvastatin for Healthy Subjects This Phase 1 medical study run by Chong Kun Dang Pharmaceutical needs participants to evaluate whether CKD-508 will have tolerable side effects & efficacy ...

5. ctv.veeva.com ctv.veeva.com/study/a-study-to-investigate-the-safety-tolerability-pk-and-pd-of-ckd-508-in-healthy-participants

A Study to Investigate the Safety, Tolerability, PK, and PD of ... This Phase 1, randomized, parallel-group, placebo-controlled, double-blinded study aims to evaluate the safety, PK, and PD of CKD-508 when ...

6. adisinsight.springer.com adisinsight.springer.com/drugs/800051723

CKD 508 - AdisInsight - Springer Chong Kun Dang Pharmaceutical is developing an oral formulation of CKD 508, a cholesterol ester transfer protein inhibitor, ...

7. atherosclerosis-journal.com atherosclerosis-journal.com/article/S0021-9150(20)31395-2/abstract

Old target, but new drug: 2nd generation cetp inhibitor ... The aim of this study was to examine the therapeutic effect of CKD-508, an orally available CETP inhibitor with improved efficacy and safety.