NCT04494269

A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls

An Open-label, Multi-center, Single-dose, Parallel-group Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to compare the pharmacokinetic and safety of tegoprazan following single oral dose in subjects with hepatic impairment versus healthy control.

Detailed description

\[Pharmacokinetic Assessment\] * Measurements \- Tegoprazan and desmethyl tegoprazan (M1) in blood and urine * Endpoints * Primary endpoints: AUClast and Cmax of tegoprazan and M1 * Secondary endpoints: CL/F, t1/2, AUCinf, and fu of tegoprazan; CLrenal and Ae of tegoprazan and M1 \[Safety Assessment\] * Adverse events (AEs) * Clinical laboratory tests * Vital sign * Physical examination * Electrocardiogram (ECG)

Conditions

• Hepatic Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	Tegoprazan 50mg	Oral administration once daily

Timeline

• Start date: 2020-09-08
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2020-07-31
• Last updated: 2020-11-09

Locations

3 sites across 1 country: South Korea