Status:
NOT_YET_RECRUITING
A Drug-drug Interaction Study to Investigate the Pharmacokinetic Interactions Between CKD-508, Midazolam, and Rosuvastatin in Healthy Adult Male Participants
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 16 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06979973
Start Date
May 14 2025
End Date
August 16 2025
Last Update
May 20 2025
Active Locations (1)
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1
Research Site
Glendale, California, United States, 91206