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

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

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

I am a man aged between 18 and 45.

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