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AC430 will be administered, orally under fasting conditions (fasting 4 hours before and 2 hours after dosing) with approximately 240 mL of water either once daily or twice daily. It is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.
A dose-finding study of AC430 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| AC430 | Active Comparator | AC430 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC430 | Drug | Healthy volunteers will either receive AC430 or placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430. |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the pharmacodynamic effects of single and multiple oral doses of AC430. |
| Measured at specific timepoints prior to and following dosing regimen. |
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Important Inclusion Criteria:
Important Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guy Gammon, MB BS, MRCP | Interim Chief Medical Officer / Ambit Biosciences Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Madison | Wisconsin | 53718 | United States |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |