NCT03704675

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: MedPacto, Inc. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TEW-7197	Administered orally

Timeline

• Start date: 2018-08-08
• Primary completion: 2018-09-09
• Completion: 2018-10-20
• First posted: 2018-10-15
• Last updated: 2020-04-14

Locations

1 site across 1 country: South Korea