A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function

Phase 1

Completed

• Conditions: Liver Dysfunction
• Interventions: Drug: CKD-501

• Registration Number: NCT02005744
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

The purpose of this study is to evaluate pharmacokinetics of CKD-501 in patients with impaired hepatic function compared with normal hepatic function.

Detailed Description

A Phase 1, Non-randomized, Open, Parallel-Group study.

Study Timeline

• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-09
• Study Start: 2014-03
• Status Verified: 2014-05
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Child Pugh B	CKD-501	CKD-501 will be administered to patients who are included Child Pugh B
Subject who are matched Child Pugh A	CKD-501	CKD-501 will be administered to the Subjects who are matched Child Pugh A
Subject who are matched Child Pugh B	CKD-501	CKD-501 will be administered to the subjects who are matched Child Pugh B
Child Pugh A	CKD-501	CKD-501 will be administered to patients who are included Child Pugh A

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration(last) and Cmax of CKD-501	0 to 48 hours	Sampling timepoint(hours); : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48

Secondary Outcome Measures

Name	Time	Method
Tmax, Area Under the Concentration(inf), T1/2 and Clearance/F of CKD-501 and its metabolite	0 to 48 hours	Sampling timepoint(hours); : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Metabolic ratio(metabolite/CKD-501)	0 to 48 hours	sampling timepoint(hours); : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Area Under the Concentration(last) and Cmax of the metabolite	o to 48 hours	sampling timepoint(hours); : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Fraction Unbound of CKD-501 and its metabolite	1 and 8 hours	sampling timepoint(hours); : 1, 8

Trial Locations

Locations (1)

Yonsei University Severance Hospital; 🇰🇷 Soeul, Korea, Republic of