Healthy
Conditions
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
Interventions
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of midazolam | 24 hours | Maximum plasma concentrations of midazolam after single dose |
| AUClast of midazolam | 24 hours | Area under the concentration-time curve of midazolam after single dose |
| AUCinf of midazolam | From 0 hours to 24 hours on Day 1 and Day 24 | Area under the concentration-time curve extrapolated to infinity of midazolam |
| Cmax of Rosuvastatin | 72 hours | Maximum plasma concentrations of rosuvastatin after single dose |
| AUClast of rosuvastatin | 72 hours | Area under the concentration-time curve of rosuvastatin after single dose |
| AUCinf of rosuvastatin | From 0 hours to 72 hours on Day 1 and Day 24 | Area under the concentration-time curve extrapolated to infinity of rosuvastatin |
| Cmax,ss of CKD-508 | 24 hours | Maximum plasma concentration at steady state of CKD-508 |
| AUCtau,ss of CKD-508 | 24 hours | Area under the concentration time curve until the end of dosing interval at steady state of CKD-508 |
| Cmin,ss of CKD-508 | 24 hours | Minimum plasma concentration at steady state of CKD-508 |
Countries
United States
Outcome results
None listed