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

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

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

Study Overview

• Status: Completed
• Conditions: Liver Dysfunction
• Intervention / Treatment: Drug: CKD-501

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Soeul, Korea, Republic of
    • Yonsei University Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

A. 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

B. 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.

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Child Pugh A; CKD-501 will be administered to patients who are included Child Pugh A	Drug: CKD-501; CKD-501 0.5mg, PO(per oral), once; Other Names: Lobeglitazone
Experimental: Child Pugh B; CKD-501 will be administered to patients who are included Child Pugh B	Drug: CKD-501; CKD-501 0.5mg, PO(per oral), once; Other Names: Lobeglitazone
Experimental: Subject who are matched Child Pugh A; CKD-501 will be administered to the Subjects who are matched Child Pugh A	Drug: CKD-501; CKD-501 0.5mg, PO(per oral), once; Other Names: Lobeglitazone
Experimental: Subject who are matched Child Pugh B; CKD-501 will be administered to the subjects who are matched Child Pugh B	Drug: CKD-501; CKD-501 0.5mg, PO(per oral), once; Other Names: Lobeglitazone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Vital signs	up to 8 days
Physical examination	up to 8 days
Laboratory tests	up to 8 days
Adverse events	up to 8 days

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): July 4, 2016
• Last Update Submitted That Met QC Criteria: July 1, 2016
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: CKD-501
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: 19HI13018