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This clinical trial will determine the bioavailability and effect of food on TP-3654 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Randomized, single-dose, 3-period, 3-way cross-over study to assess the relative bioavailability of TP-3654 capsule formulation (1:5 ratio of API:excipient) vs capsule formulations using a 1:3 and 1:2 of API:excipient ratio. |
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| Part B | Experimental | Randomized, single-dose, 3-period, 3-way cross-over study to evaluate the effect of food on the PK of the Sponsor's selected TP-3654 capsule formulation (1:3 or 1:2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TP-3654 | Drug | capsule, oral administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Cmax for relative bioavailability of TP-3654 in Part A | Analysis of the maximum concentration (Cmax) of the relative bioavailability of TP-3654 in two different capsule formulations utilizing the ratio of adjusted geometric means | 13 days |
| The Cmax for relative bioavailability of TP-3654 in Part B | Analysis of the maximum concentration (Cmax) of the relative bioavailability of the selected capsule formulation of TP-3654 from Part A when administered in fed versus fasting conditions utilizing the ratio of adjusted geometric means. | 13 days |
| The AUC for relative bioavailability of TP-3654 in Part A | Analysis of the area under the concentration (AUC) time curve of the relative bioavailability of TP-3654 in two different capsule formulations utilizing the ratio of adjusted geometric means | 13 days |
| The AUC for relative bioavailability of TP-3654 in Part B | Analysis of the area under the concentration (AUC) time curve of the relative bioavailability of the selected capsule formulation of TP-3654 from Part A when administered in fed versus fasting conditions utilizing the ratio of adjusted geometric means. | 13 days |
| Measure | Description | Time Frame |
|---|---|---|
| The number of adverse events and their severity as reported in healthy adult participants | 47 days |
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Inclusion Criteria:
Exclusion Criteria:
male, female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frontage Clinical | Secaucus | New Jersey | 07094 | United States |
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| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C117473 | TP 3654 |
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