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

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: Midazolam; Drug: Rosuvastatin; Drug: CKD-508 Tablet

• Registration Number: NCT06979973
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study Start: 2025-05-14
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-08-16
• Study Completion: 2025-08-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Midazolam, Rosuvastatin, CKD-508	Midazolam	Single dose of Midazolam Single and Multiple dose of Rosuvastatin Multiple dose of CKD-508
Midazolam, Rosuvastatin, CKD-508	Rosuvastatin	Single dose of Midazolam Single and Multiple dose of Rosuvastatin Multiple dose of CKD-508
Midazolam, Rosuvastatin, CKD-508	CKD-508 Tablet	Single dose of Midazolam Single and Multiple dose of Rosuvastatin Multiple dose of CKD-508

Primary Outcome Measures

Name	Time	Method
Cmax of midazolam	24 hours	Maximum plasma concentrations of midazolam 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
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Glendale, California, United States