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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-508 dose level 1 | Experimental | Multiple dose of CKD-508 tablets |
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| CKD-508 dose level 2 | Experimental | Multiple dose of CKD-508 tablets |
|
| CKD-508 dose level 3 | Experimental | Multiple dose of CKD-508 tablets |
|
| CKD-508 dose level 4 | Experimental | Multiple dose of CKD-508 tablets |
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| Placebo | Placebo Comparator | Multiple dose of placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-508 Tablet | Drug | Investigational drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) | 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. | up to Day 56 |
| Maximum Plasma Concentrations of CKD-508 after single and multiple doses | Peak plasma concentration (Cmax) | up to Day 56 |
| Time to Maximum Plasma Concentrations of CKD-508 after single and multiple doses | Time of peak plasma concentration (Tmax) | up to Day 56 |
| Area Under the Concentration-Time Curve of CKD-508 after single dose | Area under the concentration-time curve from pre-dose (time 0) to post-dose 24 h (AUC0-24h) after a single dose | up to 24 hours post-dose |
| Area Under the Concentration-Time Curve of CKD-508 after multiple doses | Area under the concentration-time curve from pre-dose (time 0) to post-dose 24 h (AUCtau.ss) after multiple doses | up to Day 56 |
| Change from baseline in CETP activity after multiple doses of CKD-508 or placebo | The absolute values and percentages of change from baseline in CETP activity measured in blood after multiple doses of CKD-508 or placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) after multiple doses of CKD-508 or placebo | The absolute values and percentages of change from baseline in LDL-C measured in blood after multiple doses of CKD-508 or placebo | up to Day 40 |
| Change from Baseline in High-density Lipoprotein Cholesterol (HDL-C) after multiple doses of CKD-508 or placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | 91206 | United States |
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| Placebo Tablet | Drug | Placebo |
|
| up to Day 56 |
The absolute values and percentages of change from baseline in HDL-C measured in blood after multiple doses of CKD-508 or placebo |
| up to Day 40 |
| Change from Baseline in CETP mass after multiple doses of CKD-508 or placebo | The absolute values and percentages of change from baseline in CETP protein concentration measured in blood after multiple doses of CKD-508 or placebo | up to Day 56 |
| 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 |