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The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of 3 escalating loading and maintenance dose regimens of CG100649 administered orally for 7 total days in healthy volunteers.
Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used CTCAE and normal ranges if relevant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CG100649 | Experimental | By the amount of doses, the groups are classified |
|
| Naproxen | Active Comparator | By the amount of doses, the groups are classified |
|
| Placebo | Placebo Comparator | By the amount of doses, the groups are classified |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CG100649 | Drug | 6 subjects: study drug 2 subjects: placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (normal results for safety tests) | Cardiovascular: BP,ECG, Holter monitoring GI: Fecal occult blood Kidney: Urine electrolyte test Adverse events Physical examination, vital signs | 27days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seonggu Ro | CrystalGenomics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| C000599293 | CG100649 |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo |
| Drug |
6 subjects: study drug 2 subjects: placebo |
|
| Naproxen | Drug | 6 subjects: study drug 2 subjects: placebo |
|
|
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |