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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT02005744
Collaborator
(none)
26
Enrollment
1
Location
4
Arms
23.1
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function Compared With Normal Hepatic Function
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. Fraction Unbound of CKD-501 and its metabolite [1 and 8 hours]

      sampling timepoint(hours) : 1, 8

    3. 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

    4. 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

    Other Outcome Measures

    1. Vital signs [up to 8 days]

    2. Physical examination [up to 8 days]

    3. Laboratory tests [up to 8 days]

    4. Adverse events [up to 8 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    1. 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

    1. 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)

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

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

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

    4. The subjects with high blood pressure or low blood pressure(systolic blood pressure

    150mmHg or <100mmHg, diastolic blood pressure>90mmHg or <60mmHg)

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei University Severance Hospital Soeul Korea, Republic of

    Sponsors and Collaborators

    • Chong Kun Dang Pharmaceutical

    Investigators

    • Principal Investigator: Min Soo Park, Ph.D. M.D, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT02005744
    Other Study ID Numbers:
    • 19HI13018
    First Posted:
    Dec 9, 2013
    Last Update Posted:
    Jul 4, 2016
    Last Verified:
    May 1, 2014
    Keywords provided by Chong Kun Dang Pharmaceutical
    CKD-501
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Jul 4, 2016