Effect of Food on the Pharmacokinetics of TEW-7197 in Healthy Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Clinical Trial for the Safety, Tolerability, and Pharmacokinetics of TEW-7197 Under Fed or Fasting in Healthy Male Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: TEW-7197


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy sterile males BMI 18.0kg/m2 - 27.0 kg/m2 No congenital or chronic disease and no pathological symptoms or pathological findings Investigator confirm that the subject is eligible through a medical examination (medical history taking ,vital signs, ECG, cardiac ultrasonography, blood science) Exclusion Criteria: Has pathological symptoms or pathological findings Has a history of disease that may affect the absorption, distribution, metabolism and excretion of a drug SBP>140 or <90 mmhg , DBP>90 or <60mmHg ,Pulse>100 No abnormal Clinical Lab findings

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (Fasted->Fed)<br>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 | Drug: TEW-7197<br>* Administered orally<br>* Other names: Vactosertib;|
| Experimental: Group II(Fed->Fasted)<br>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 | Drug: TEW-7197<br>* Administered orally<br>* Other names: Vactosertib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |