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Completed

NCT Number: NCT06979973

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

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

midazolam

Drug

midazolam syrup

Rosuvastatin

Drug

Rosuvastatin

CKD-508 Tablet

Drug

CKD-508

Primary outcomes

  1. Cmax of midazolam

    Time frame: 24 hours

    Maximum plasma concentrations of midazolam after single dose

  2. AUClast of midazolam

    Time frame: 24 hours

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

  3. AUCinf of midazolam

    Time frame: From 0 hours to 24 hours on Day 1 and Day 24

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

  4. Cmax of Rosuvastatin

    Time frame: 72 hours

    Maximum plasma concentrations of rosuvastatin after single dose

  5. AUClast of rosuvastatin

    Time frame: 72 hours

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

  6. AUCinf of rosuvastatin

    Time frame: From 0 hours to 72 hours on Day 1 and Day 24

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

  7. Cmax,ss of CKD-508

    Time frame: 24 hours

    Maximum plasma concentration at steady state of CKD-508

  8. AUCtau,ss of CKD-508

    Time frame: 24 hours

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

  9. Cmin,ss of CKD-508

    Time frame: 24 hours

    Minimum plasma concentration at steady state of CKD-508

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 20, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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