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

Chong Kun Dang

Status and phase

Not yet enrolling

Phase 1

Conditions

Healthy

Treatments

Drug: CKD-508 Tablet

Drug: Midazolam

Drug: Rosuvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT06979973

A104_03DDI2501

Details and patient eligibility

About

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

Enrollment

24 estimated patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.