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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004940-35 | |||
| 2704-026 |
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Reached sufficient pharmacokinetic exposures
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The purpose of this study is to determine whether AMAP102 is safe and well tolerated by humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Groups SAD | Experimental | AMAP102 or Placebo as single ascending doses in five groups |
|
| Groups MAD | Experimental | AMAP102 or Placebo as multiple ascending doses twice daily for seven days in two groups |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMAP102 | Drug | AMAP102 or Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability determined by adverse events, vital signs, ECG and clinical laboratory evaluations | During residential period and at follow up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the pharmacokinetic profile of AMAP102 after one oral dose and after multiple oral doses during twice daily dosing for seven days, and compare the pharmacokinetic profile for men and women | PK sampling at defined timepoints during residential period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Joseph Chiesa, MD FFPM FICR CSci | Covance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Ltd. | Leeds | LS2 9LH | United Kingdom |
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