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

NCT06979973 | Completed Phase 1 FDA Drug

• 1 other identifier: A104_03DDI2501
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• Cmax of midazolam

  Maximum plasma concentrations of midazolam after single dose

  24 hours

• AUClast of midazolam

  Area under the concentration-time curve of midazolam after single dose

  24 hours

• AUCinf of midazolam

  Area under the concentration-time curve extrapolated to infinity of midazolam

  From 0 hours to 24 hours on Day 1 and Day 24

• Cmax of Rosuvastatin

  Maximum plasma concentrations of rosuvastatin after single dose

  72 hours

• AUClast of rosuvastatin

  Area under the concentration-time curve of rosuvastatin after single dose

  72 hours

• AUCinf of rosuvastatin

  Area under the concentration-time curve extrapolated to infinity of rosuvastatin

  From 0 hours to 72 hours on Day 1 and Day 24

• Cmax,ss of CKD-508

  Maximum plasma concentration at steady state of CKD-508

  24 hours

• AUCtau,ss of CKD-508

  Area under the concentration time curve until the end of dosing interval at steady state of CKD-508

  24 hours

• Cmin,ss of CKD-508

  Minimum plasma concentration at steady state of CKD-508

  24 hours

Study Arms (1)

Midazolam, Rosuvastatin, CKD-508

EXPERIMENTAL

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

Drug: Midazolam; Drug: Rosuvastatin; Drug: CKD-508 Tablet

Interventions

Midazolam DRUG

midazolam syrup

Midazolam, Rosuvastatin, CKD-508

Rosuvastatin DRUG

Rosuvastatin

Midazolam, Rosuvastatin, CKD-508

CKD-508 Tablet DRUG

CKD-508

Midazolam, Rosuvastatin, CKD-508

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Research Site

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

Midazolam; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 20, 2025
• Study Start: May 14, 2025
• Primary Completion: August 17, 2025
• Study Completion: August 17, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)