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

NCT ID: NCT06979973

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-14
• Study Completion Date: 2025-08-16

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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Midazolam, Rosuvastatin, CKD-508

Single dose of Midazolam Single and Multiple dose of Rosuvastatin Multiple dose of CKD-508

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

midazolam syrup

Rosuvastatin

Intervention Type: DRUG

Rosuvastatin

CKD-508 Tablet

Intervention Type: DRUG

CKD-508

Interventions

Midazolam

midazolam syrup

Intervention Type: DRUG

Rosuvastatin

Rosuvastatin

Intervention Type: DRUG

CKD-508 Tablet

CKD-508

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Glendale, California, United States

Countries

United States

Facility Contacts

Sophie Lee

Role: primary

study.losangeles@parexel.com

800-228-7425

Other Identifiers

A104_03DDI2501

Identifier Type: -

Identifier Source: org_study_id