Clinical trial NCT06979973: A Drug-drug Interaction Study to Investigate the Pharmacokinetic Interactions Between CKD-508, Midazolam, and Rosuvastatin in Healthy Adult Male Participants
Official title: A Phase 1, Open-label, Drug-Drug Interaction Study to Assess the Pharmacokinetic Interactions Between CKD-508, Midazolam, and Rosuvastatin in Healthy Adult Male Participants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Cmax of midazolam
timeFrame: 24 hours
measure: AUClast of midazolam
timeFrame: 24 hours
measure: AUCinf of midazolam
timeFrame: From 0 hours to 24 hours on Day 1 and Day 24
measure: Cmax of Rosuvastatin
timeFrame: 72 hours
measure: AUClast of rosuvastatin
timeFrame: 72 hours
measure: AUCinf of rosuvastatin
timeFrame: From 0 hours to 72 hours on Day 1 and Day 24
measure: Cmax,ss of CKD-508
timeFrame: 24 hours
measure: AUCtau,ss of CKD-508
timeFrame: 24 hours
measure: Cmin,ss of CKD-508
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
Study officials:
References: