Healthy Subjects
Conditions
Brief summary
This Phase 1, randomized, parallel-group, placebo-controlled, double-blinded study aims to evaluate the safety, PK, and PD of CKD-508 when administered multiple times once daily to healthy participants.
Interventions
DRUGCKD-508 Tablet
Investigational drug
DRUGPlacebo Tablet
Placebo
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 and female adults aged 18 to 55 years at screening. * Healthy participants were determined by pre-study medical evaluation and judged by the Investigator. * Female participants of non-childbearing potential (surgically sterile \[hysterectomy or oophorectomy\]) or postmenopausal (amenorrhea for more than 12 months with follicle-stimulating hormone \[FSH\] in the postmenopausal range as confirmed by an FSH test). * Female participants of childbearing potential who agree to use highly effective method of contraception in the protocol consistently and correctly from screening until the last dose administration of the study intervention. * Male participants must be unable to procreate (defined as surgically sterile \[had a vasectomy\] ≥6 months prior screening) or must agree to use a highly effective contraception as detailed in the protocol during the intervention period and for at least 90 days after the study completion and refrain from donating sperm during this period. * 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) \<90 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. * 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. * Currently taking a lipid-modifying medication. * History of hypersensitivity to CKD-508 or medicinal products with similar chemical structures. * Individual unlikely to comply with the protocol requirements, instructions, and study-related restrictions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) | up to Day 56 | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE will be defined as any AE that emerges during treatment (i.e., AE which starts during or after study drug administration or pre-existed and worsened in severity after study drug administration), and those will be analyzed for the purpose of safety analysis. The number of participants who experience a TEAE will be reported. |
| Maximum Plasma Concentrations of CKD-508 after single and multiple doses | up to Day 56 | Peak plasma concentration (Cmax) |
| Time to Maximum Plasma Concentrations of CKD-508 after single and multiple doses | up to Day 56 | Time of peak plasma concentration (Tmax) |
| Area Under the Concentration-Time Curve of CKD-508 after single dose | up to 24 hours post-dose | Area under the concentration-time curve from pre-dose (time 0) to post-dose 24 h (AUC0-24h) after a single dose |
| Area Under the Concentration-Time Curve of CKD-508 after multiple doses | up to Day 56 | Area under the concentration-time curve from pre-dose (time 0) to post-dose 24 h (AUCtau.ss) after multiple doses |
| Change from baseline in CETP activity after multiple doses of CKD-508 or placebo | up to Day 56 | The absolute values and percentages of change from baseline in CETP activity measured in blood after multiple doses of CKD-508 or placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) after multiple doses of CKD-508 or placebo | up to Day 40 | The absolute values and percentages of change from baseline in LDL-C measured in blood after multiple doses of CKD-508 or placebo |
| Change from Baseline in High-density Lipoprotein Cholesterol (HDL-C) after multiple doses of CKD-508 or placebo | up to Day 40 | The absolute values and percentages of change from baseline in HDL-C measured in blood after multiple doses of CKD-508 or placebo |
| Change from Baseline in CETP mass after multiple doses of CKD-508 or placebo | up to Day 56 | The absolute values and percentages of change from baseline in CETP protein concentration measured in blood after multiple doses of CKD-508 or placebo |
| The effects on the cardiac repolarization by assessing the QTc interval after single and multiple doses of CKD-508 or placebo | up to Day 56 | — |
Countries
United States
Outcome results
None listed