Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT04494269
Status:
UNKNOWN
Last Update Posted:
2020-11-09
First Post:
2020-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
Sponsor:
HK inno.N Corporation
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
* 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)
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: