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

NCT ID: NCT02005744

Last Updated: 2016-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-02-29

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.

Conditions

Liver Dysfunction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Child Pugh A

CKD-501 will be administered to patients who are included Child Pugh A

Group Type: EXPERIMENTAL

CKD-501

Intervention Type: DRUG

CKD-501 0.5mg, PO(per oral), once

Child Pugh B

CKD-501 will be administered to patients who are included Child Pugh B

Group Type: EXPERIMENTAL

CKD-501

Intervention Type: DRUG

CKD-501 0.5mg, PO(per oral), once

Subject who are matched Child Pugh A

CKD-501 will be administered to the Subjects who are matched Child Pugh A

Group Type: EXPERIMENTAL

CKD-501

Intervention Type: DRUG

CKD-501 0.5mg, PO(per oral), once

Subject who are matched Child Pugh B

CKD-501 will be administered to the subjects who are matched Child Pugh B

Group Type: EXPERIMENTAL

CKD-501

Intervention Type: DRUG

CKD-501 0.5mg, PO(per oral), once

Interventions

CKD-501

CKD-501 0.5mg, PO(per oral), once

Intervention Type: DRUG

Other Intervention Names

Lobeglitazone

Eligibility Criteria

Inclusion Criteria

[The subjects with impaired hepatic function]

1. The subjects who are 19 to 64 years old

2. The subjects with stable hepatic disease and impaired hepatic function as Child-Pugh A or B

3. Body Weight ≥ 55kg

4. If females, Negative for pregnancy test at the screening and pre dose of Day 1

5. The subjects who agreed with performing contraception during the study

6. The subjects who agreed with written informed consent

[The subjects with normal hepatic function]

1. The subjects who are 19 to 64 years old

2. The subjects who are matched impaired hepatic function by gender, age(± 5years) and body weight(± 10kg)

3. If females, Negative for pregnancy test at the screening and pre dose of Day 1

4. The subjects who agreed with performing contraception during the study

5. The subjects who agreed with written informed consent

Exclusion Criteria

[The subjects with impaired hepatic function]

1. The subjects with impaired hepatic function as Child-Pugh C

2. The subjects had a portosystemic shunt surgery

3. The subjects had a liver transplantation or unsuitable for the study by the investigator's judgement(for examples, hepatic encephalopathy grade 3 or 4, stroke, heart failure, cancer etc.) but The subject is eligible to participate if had not chemotherapy or radiofrequency ablation therapy within 6months)

4. The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product

5. The subjects who took drugs or medicine which can be effected in metabolism of Cytochrome P450 within 14days prior to Day 1

6. Positive for anti-HIV Ab or venereal disease research laboratory etc.

[The subjects with normal hepatic function]

1. The subjects with liver disease or abnormal Laboratory test(Asparate transaminase >1.25 fold of upper normal limit, Alanine transaminase>1.25 fold of upper normal limit, Total bilirubin >1.5 fold of upper normal limit)

2. The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product

3. Estimated Glomerular filtration rate < 60 mL/min/1.73m2 by Modification of Diet in Renal Disease formula

4. Positive for HBsAg, anti-Hepatitis C virus Ab, anti-HIV Ab or venereal disease research laboratory

5. The subjects with high blood pressure or low blood pressure(systolic blood pressure >150mmHg or <100mmHg, diastolic blood pressure>90mmHg or <60mmHg)

6. The subjects who took drugs or medicine which can be effected in metabolism of Cytochrome P450 within 14days prior to Day 1 etc.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Soo Park, Ph.D. M.D

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Yonsei University Severance Hospital

Soeul, , South Korea

Countries

South Korea

Other Identifiers

19HI13018

Identifier Type: -

Identifier Source: org_study_id