NCT05202912

Food Effect Study of IDX-1197 in Healthy Subjects

A Randomized, Open-label, Single-dose, Crossover Phase 1 Clinical Trial to Evaluate the Effects of Food or Ethnicity on the Pharmacokinetics and Safety/Tolerability of IDX-1197 After Single Oral Administration in Healthy Male Korean, Chinese, and Caucasian Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Idience Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Study to Evaluate the Effects of Food or Ethnicity on the Pharmacokinetics and Safety/Tolerability of IDX-1197 After Single Oral Administration in Healthy Male Korean, Chinese, and Caucasian Volunteers

Conditions

• Healthy Male

Interventions

Type	Name	Description
DRUG	IDX-1197(After a meal)	randomized, open-label, single-dose, 2-period, 2-sequence crossover study in healthy male Korean and Caucasian volunteers
DRUG	IDX-1197(fasting)	open-label, single-dose study in Chinese male volunteers

Timeline

• Start date: 2022-01-16
• Primary completion: 2022-07-23
• Completion: 2022-07-23
• First posted: 2022-01-24
• Last updated: 2022-08-09

Locations

1 site across 1 country: South Korea