NCT04733001

A Study to Investigate the Effect of Food on the Pharmacokinetics of HSG4112

A Randomized, Open-label, Single Dose, 3-way Crossover Clinical Trial to Investigate the Effect of Food on the Pharmacokinetics of HSG4112 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Glaceum · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

1. Study Objective: The objective of this clinical trial is to investigate the effect of food on the pharmacokinetics of HSG4112 after oral administration in healthy male subjects. 2. Study Design and Plan: This study is a randomized, open-label, single dose, 3-way crossover clinical trial. A unique randomization number will be assigned to each subject deemed eligible to participate in the study based on the inclusion/exclusion criteria. A total of 12 subjects will be randomized to 6 different sequence groups. Each subject will receive a single dose of HSG4112 480 mg via oral administration under fasted, low-fat diet, and high-fat diet conditions, with a washout period of 21 days in between each dosing.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	HSG4112	Once-daily oral administration

Timeline

• Start date: 2020-07-12
• Primary completion: 2021-02-10
• Completion: 2021-02-10
• First posted: 2021-02-01
• Last updated: 2021-09-24

Locations

1 site across 1 country: South Korea