Clinical trial NCT02005744: A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function
Official title: A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function Compared With Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Dysfunction
Keywords: CKD-501
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Concentration(last) and Cmax of CKD-501
timeFrame: 0 to 48 hours
Secondary outcomes:
measure: Tmax, Area Under the Concentration(inf), T1/2 and Clearance/F of CKD-501 and its metabolite
timeFrame: 0 to 48 hours
measure: Fraction Unbound of CKD-501 and its metabolite
timeFrame: 1 and 8 hours
measure: Area Under the Concentration(last) and Cmax of the metabolite
timeFrame: o to 48 hours
measure: Metabolic ratio(metabolite/CKD-501)
timeFrame: 0 to 48 hours
Other outcomes:
measure: Vital signs
timeFrame: up to 8 days
measure: Physical examination
timeFrame: up to 8 days
measure: Laboratory tests
timeFrame: up to 8 days
measure: Adverse events
timeFrame: up to 8 days
Locations:
city: Soeul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Min Soo Park, Ph.D. M.D
role: PRINCIPAL_INVESTIGATOR
References: