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This Phase 1, single-dose study will be conducted in adult female subjects (N = 16) who are in general good health and selected for participation in the study according to the selection criteria. This study will assess the effect of food on the pharmacokinetics of PT2385 Tablets. The study will consist of two periods and will be conducted in a crossover fashion.
Subjects will be randomized in equal numbers to two sequences of meal conditions (fasting and non-fasting). Serial blood samples will be collected for after dose administration in each period. Subjects will be confined at the clinical research for a portion of each period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasted | Experimental | PT2385 taken after fasting. |
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| Non-Fasting | Experimental | PT2385 taken after eating a high calorie meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PT2385 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of food on the pharmacokinetics of a single dose of PT2385 Tablets administered to normal healthy adult subjects (Cmax). | Peak Plasma Concentration (Cmax) will be assessed in both the fasting and non-fasting conditions and compared. | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of PT2385 Tablets in normal healthy adult subjects by reviewing the incidence of treatment-emergent adverse events. | Analyses will consist of data summaries for AEs/SAEs | 30 days |
| Pharmacodynamic (PD) effects of treatment with PT2385 Tablets (plasma levels). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Clinical | West Bend | Wisconsin | United States |
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| ID | Term |
|---|---|
| C000614279 | PT2385 |
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Variability in biomarkers will be correlated with plasma levels of PT2385. |
| 6 days |