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Participants in this study will receive 200 milligram (mg) TEW-7197 taken at 7days apart. One dose will be given under fasting . The Other dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 2weeks not including screening.
Through screening (D-30 ~ D-1) prior to the first dose of the investigational product, a total of 16 subjects (Group 1: 8 subjects, Group 2: 8 subjects) who were eligible for the inclusion criteria and exclusion criteria were enrolled. This clinical study has a randomized, open, single dose, 2-sequence, 2-period cross-over design and TEW-7197 50 mg x 4 tablets were administered as a single dose in the same individual for 2 periods after fasting or a high fat diet, and each period was repeated with an interval of at least 1 week of wash-out. Pharmacokinetics and safety were evaluated in all subjects according to the planned schedule
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Fasted->Fed) | Experimental | Group 1 received a single oral dose in a fasting condition in Period 1, followed by a single oral dose after a high-fat diet in Period 2 |
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| Group II(Fed->Fasted) | Experimental | Group 2 received a single oral dose after a high-fat diet in Period 1, followed by a single oral in a fasting condition in Period 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEW-7197 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics:Maximum Concentration (Cmax) | Maximum Concentration (Cmax) | Pre-dose through 24 hours post-dose in each period of the. study |
| Pharmacokinetics:Area Under the Concentration Curve (AUC) | Area Under the Concentration Curve (AUC) of TEW-7197 | Pre-dose through 24 hours post-dose in each period of the. study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunjin Hwang, MD | MedPacto, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | 47392 | South Korea |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2018 | Feb 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000590371 | vactosertib |
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