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To assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of CKD-504 compared to placebo in healthy Korean and Caucasian adult subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-504 | Experimental | investigational Drug |
|
| Placebo | Placebo Comparator | investigational Drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-504 | Drug | orally administered once with investigational drug assigned on 1d morning with 240 mL of water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of CKD-504 | Peak Plasma Concentration (Cmax) of CKD-504 | Day1, Day2, Day3, Day4 |
| AUC of CKD-504 | Area under the plasma concentration versus time curve (AUC) of CKD-504 | Day1, Day2, Day3, Day4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Ji Song | Contact | 82-2-3149-7853 | songmj@ckdpharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000722332 | CKD-504 |
| D056572 | Histone Deacetylase Inhibitors |
| ID | Term |
|---|---|
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Placebo | Drug | orally administered |
|
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |