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A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAT-1251 Single Dose | Experimental | Oral solution of PAT-1251, 150 - 4000 mg administered once |
|
| Placebo Single Dose | Placebo Comparator | Matching placebo solution administered once |
|
| PAT-1251 Multiple Dose | Experimental | Oral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days |
|
| Placebo Multiple Dose | Experimental | Matching placebo tablets administered daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAT-1251 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Determination of adverse events will include assessment of vital signs, ECG, clinical laboratory and physical examination | one to seven days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | one to seven days | |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | one to seven days | |
| Time to Maximum Observed Plasma Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Holme, Ph.D. | PharmAkea, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Ltd. | Leeds | LS2 9LH | United Kingdom |
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| Label | URL |
|---|---|
| Sponsor Website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 14, 2017 | |
| Reset | Jun 22, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 14, 2017 | Jun 22, 2018 |
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| Drug |
|
Comparative pharmacokinetics of single dose administered in a fasted state and following a meal |
| one to seven days |
| Terminal elimination half-life (t½) | one to seven days |