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

Liver Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005744
• Other study ID #: 19HI13018
• Status: Completed
• Phase: Phase 1
• First received: December 4, 2013
• Last updated: July 1, 2016
• Start date: March 2014
• Est. completion date: February 2016

Study information

• Verified date: May 2014
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 64 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Liver Dysfunction

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Severance Hospital	Soeul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vital signs		up to 8 days	Yes
Other	Physical examination		up to 8 days	Yes
Other	Laboratory tests		up to 8 days	Yes
Other	Adverse events		up to 8 days	Yes
Primary	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	No
Secondary	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	No
Secondary	Fraction Unbound of CKD-501 and its metabolite	sampling timepoint(hours); : 1, 8	1 and 8 hours	No
Secondary	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	No
Secondary	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	No