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Food Effect Study of IDX-1197 in Healthy Subjects

NCT05202912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2022-08-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Idience Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-16
Primary Completion
2022-07-23
Completion
2022-07-23

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05202912 on ClinicalTrials.gov