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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704675
• Other study ID #: MP-VAC-105
• Status: Completed
• Phase: Phase 1
• Start date: August 8, 2018
• Est. completion date: October 20, 2018

Study information

• Verified date: April 2020
• Source: MedPacto, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 20, 2018
• Est. primary completion date: September 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• TEW-7197
Administered orally

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
MedPacto, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics:Maximum Concentration (Cmax)	Maximum Concentration (Cmax)	Pre-dose through 24 hours post-dose in each period of the. study
Primary	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