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

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ClinicalTrials.gov Identifier: NCT02005744
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : July 4, 2016
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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
Liver Dysfunction Drug: CKD-501 Phase 1

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

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Study Type : Interventional  (Clinical Trial)
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 : March 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

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 Name: 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 Name: 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 Name: 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 Name: Lobeglitazone




Primary Outcome Measures :
  1. Area Under the Concentration(last) and Cmax of CKD-501 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 and 8 hours ]

    sampling timepoint(hours)

    : 1, 8


  3. Area Under the Concentration(last) and Cmax of the metabolite [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: up to 8 days ]
  2. Physical examination [ Time Frame: up to 8 days ]
  3. Laboratory tests [ Time Frame: up to 8 days ]
  4. Adverse events [ Time Frame: up to 8 days ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005744


Locations
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Korea, Republic of
Yonsei University Severance Hospital
Soeul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Min Soo Park, Ph.D. M.D Severance Hospital

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02005744     History of Changes
Other Study ID Numbers: 19HI13018
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: May 2014

Keywords provided by Chong Kun Dang Pharmaceutical:
CKD-501

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases