Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1. CKD-508 Capsule in Single Dose | Experimental | Single dose of CKD-508 capsules |
|
| Part 1. Placebo Capsule in Single Dose | Placebo Comparator | Single dose of Placebo capsules |
|
| Part 2. CKD-508 Tablet in Single Dose | Experimental | Single dose of CKD-508 tablets for biocompartibility |
|
| Part 2. Placebo Tablet in Single Dose | Placebo Comparator | Single dose of Placebo tablets for biocompartibility |
|
| Part 3. CKD-508 Tablet in Single Dose | Experimental | Single dose of CKD-508 tablets for food effect |
|
| Part 3. Placebo Tablet in Single Dose | Placebo Comparator | Single dose of Placebo tablets for food effect |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-508 Capsule | Drug | Investigational drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability including treatment-emergent AE and treatment-emergent SAE | 28 days post the final dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma CKD-508 concentrations after dosing | Peak plasma concentration (Cmax) | 28 days post the final dose |
| Time of maximum plasma CKD-508 concentrations after dosing | Time of peak plasma concentration (Tmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwick Park Hospital | Harrow | Middlesex | HA1 3UJ | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Part 4. CKD-508 Tablet in Multiple Dose | Experimental | Multiple dose of CKD-508 tablets |
|
| Part 4. Placebo Tablet in Multiple Dose | Placebo Comparator | Multiple dose of placebo tablets |
|
| Placebo Capsule |
| Drug |
Placebo |
|
| CKD-508 Tablet | Drug | Investigational drug |
|
| Placebo Tablet | Drug | Placebo |
|
| 28 days post the final dose |
| Changes from baseline in plasma CKD-508 concentrations in time after dosing | Area under the plasma concentration versus time curve (AUC) | 28 days post the final dose |
| Changes from baseline in CETP activity after dosing | Pharmacodynamics endpoint | 28 days post the final dose |
| Changes from baseline in lipid parameters after dosing | including, but not limited to the following: LDL-C, etc. Pharmacodynamics endpoint | 14 days post the final dose |