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| ID | Type | Description | Link |
|---|---|---|---|
| 262612 | Other Identifier | Parexel |
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This is a 2-part Phase 1 cross-over study to assess the effects of food on the pharmacokinetics of PC14586 in healthy volunteers. The pharmacokinetics of PC14586 at a clinically relevant dose in Japanese participants will also be studied.
PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the p53 Y220C mutation. This Phase 1 trial will be conducted in 2 parts (Part 1 - pilot and Part 2 - pivotal) to assess the pharmacokinetics of PC14586 in healthy volunteers including Japanese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Sequence A | Experimental | Period 1 will be fed, then washout, then Period 2 will be fasted. |
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| Part 1 Sequence B | Experimental | Period 1 will be fasted, then washout, then Period 2 will be fed. |
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| Part 2 Sequence C | Experimental | Period 1 will be fed, then washout, then Period 2 will be fasted. A different dose of PC14586 will be tested. |
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| Part 2 Sequence D | Experimental | Period 1 will be fasted, then washout, then Period 2 will be fed. A different dose of PC14586 will be tested. |
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| Part 2 Japanese Cohort | Experimental | 6 Japanese participants will be administered a single dose of PC14586. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PC14586 | Drug | An oral dose of PC14586 will be used in Arms A and B (Part 1) and a different dose will be used for Arms C and D and the Japanese cohort (Part 2). |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Effect of a high-fat meal on AUClast | 2 months | |
| Part 1: Effect of a high-fat meal on AUC0-inf | 2 months | |
| Part 1: Effect of a high-fat meal on the Tmax | 2 months | |
| Part 1: Effect of a high-fat meal on the Cmax | 2 months | |
| Part 2: Effect of a high-fat meal on the AUC0-last | 7 months | |
| Part 2: Effect of a high-fat meal on the AUC0-inf | 7 months | |
| Part 2: Effect of a high-fat meal on the Tmax | 7 months | |
| Part 2: Effect of a high-fat meal on the Cmax | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Treatment emergent adverse events (TEAE) | 5 months | |
| Part 1: Clinically relevant changes in: physical examinations, vital signs, clinical laboratory tests, 12-lead triplicate electrocardiogram (ECG) | 5 months |
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Inclusion Criteria:
Inclusion criteria for Japanese participants only:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Early Phase Clinical Unit - Los Angeles | Glendale | California | 91206 | United States |
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Single-dose crossover study one dose with food and one dose without food.
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| Part 2: AUC0-last of PC14586 | 6 months |
| Part 2: AUC0-inf of PC14586 | 6 months |
| Part 2: Cmax of PC14586 | 6 months |
| Part 2: Tmax of PC14586 | 6 months |
| Part 2: The apparent clearance (CL/F) of PC14586 | 6 months |
| Part 2: Volume of distribution (Vz/F) of PC14586 | 6 months |
| Half-life of PC14586 | 6 months |
| Part 2: Incidence of Treatment emergent adverse events (TEAE) | 10 months |