A Drug-drug Interaction Study to Investigate the Pharmacokinetic Interactions Between CKD-508, Mi… (NCT06979973) | Clinical Trial Compass
CompletedPhase 1
A Drug-drug Interaction Study to Investigate the Pharmacokinetic Interactions Between CKD-508, Midazolam, and Rosuvastatin in Healthy Adult Male Participants
United States24 participantsStarted 2025-05-14
Plain-language 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
Who can participate
Age range18 Years – 45 Years
SexMALE
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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 screen…
What they're measuring
1
Cmax of midazolam
Timeframe: 24 hours
2
AUClast of midazolam
Timeframe: 24 hours
3
AUCinf of midazolam
Timeframe: From 0 hours to 24 hours on Day 1 and Day 24
4
Cmax of Rosuvastatin
Timeframe: 72 hours
5
AUClast of rosuvastatin
Timeframe: 72 hours
6
AUCinf of rosuvastatin
Timeframe: From 0 hours to 72 hours on Day 1 and Day 24