A Drug-drug Interaction Study to Investigate the Pharmacokinetic Interactions Between CKD-508, Midazolam, and Rosuvastatin in Healthy Adult Male Participants

Launched by CHONG KUN DANG PHARMACEUTICAL · May 18, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how three different medications—CKD-508, midazolam, and rosuvastatin—interact with each other in the body. The study is designed for healthy adult males aged 18 to 45 years. Researchers want to understand how these drugs affect each other’s behavior in the body, which is important to ensure safety and effectiveness when they are used together.

To be eligible, participants must be in good health, meaning they should not have serious health issues or take certain medications that might interfere with the study. They also need to be non-smokers and pass some initial health tests. The trial is not yet recruiting participants, but those who join can expect to provide informed consent, participate in health evaluations, and receive the study drugs in a controlled setting. It's an important step in ensuring that these medications can be used safely in broader populations in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.
• • 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.