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

MedPacto, Inc.16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

TEW-7197DRUG

Administered orally

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy sterile males 2. BMI 18.0kg/m2 - 27.0 kg/m2 3. No congenital or chronic disease and no pathological symptoms or pathological findings 4. Investigator confirm that the subject is eligible through a medical examination (medical history taking ,vital signs, ECG, cardiac ultrasonography, blood science) Exclusion Criteria: 1. Has pathological symptoms or pathological findings 2. Has a history of disease that may affect the absorption, distribution, metabolism and excretion of a drug 3. SBP\>140 or \<90 mmhg , DBP\>90 or \<60mmHg ,Pulse\>100 4. No abnormal Clinical Lab findings

Locations (1)

Inje University Busan Paik Hospital

Busan, South Korea

Outcomes

Primary Outcomes

Pharmacokinetics:Maximum Concentration (Cmax)

Maximum Concentration (Cmax)

Time frame: 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

Time frame: Pre-dose through 24 hours post-dose in each period of the. study

Data from ClinicalTrials.gov

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