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Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis

Sponsor
Otsuka Beijing Research Institute (Industry)
Overall Status
Completed
CT.gov ID
NCT01359462
Collaborator
(none)
11
Enrollment
1
Location
1
Arm
9
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics, pharmacology, and safety of the drug under fasting condition.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This study is to evaluate the multiple-dose pharmacokinetics, pharmacological actions and safety of Tolvaptan tablets administered orally (15 mg daily) for consecutively 7 days in Chinese adult patients with confirmed Child-Pugh Class B（score 7-9） hepatocirrhosis (accompanied by ascites).

Trial Design:

  1. Open, single-center, multi-dose pharmacokinetics study

  2. Study population:

Chinese adult patients with confirmed Child-Pugh Class B (score 7-9) hepatocirrhosis (accompanied by ascites)

  1. Dosage and mode of administration of investigational product:

Oral administration of 1 tablet (15mg) once daily, for consecutive 7 days starting from day 1 of treatment.

  1. Study duration:

Screening: 14 days in maximum; Treatment(s): 7 days; Observation: 1 day

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Study of Multiple-dose Pharmacokinetics of Tolvaptan Tablets Administered Orally (15mg Daily) for Consecutively 7 Days in Chinese Patients With Hepatocirrhosis
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tolvaptan 15mg tablet

Drug: tolvaptan
Drug: tolvaptan tablet, 15mg, Qd, for 7 days.
Other Names:
  • SAMSCA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum concentration of tolvaptan and its metabolites DM-4103 and DM-4107 [blood sample will be collected at predose, 2,4,6,8,12,24 hour of first drug administration and predose of sixth drug administration and predose,2,4,6,8,12,24 hour of seventh drug administration]

    Secondary Outcome Measures

    1. pharmacological parameter:Serum concentration of sodium and potassium [Blood sample will be collected at predose on day1;12,24hour of first dosing;before breakfast on day3 to day6;predose and 12,24hour of seventh dosing]

    2. pharmacological parameter:24-hr urine [From day-1 to day 8]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Hepatic Cirrhosis with ascites or lower extremities edema

    2. Hospitalized patients

    3. 18 years old~75 years old

    4. Inform Consent Form Signed

    Exclusion Criteria:
    1. Patients with any of the following diseases, complications or symptoms:

    • Hepatic encephalopathy (coma degree classification note 1 Grade 2 or above);

    • Malignant ascites;

    • Spontaneous bacterial peritonitis;

    • Likely to have gastrointestinal bleeding during the study period;

    • Heart failure (NYHA Note 2 Class Ⅲ andⅣ);

    • Anuria (daily urine output below 100mL);

    • Dysuria induced by urinary tract stenosis, calculus, or tumor.

    1. Patients with any of the following history:

    • With gastrointestinal bleeding within 10 days prior to screening;

    • With cerebrovascular accident within 1 month prior to screening;

    • With gout attack within 1 month prior to screening;

    • With allergy or atopy to benzodiazepine drugs (benazepril hydrochloride, etc.).

    1. Patients whose systolic blood pressure is below 90mmHg during screening;

    2. Patients with abnormal values in the following lab examination indicators:

    Serum creatinine higher than 2.5 times the upper limit of normal range, serum Na+>145mmol/L(or higher than the upper limit of normal range), serum K+> 5.5 mmol/L, uric acid>476µmol/L, child-Pugh score>10

    1. Patients ineligible for oral medication

    2. Patients in pregnancy or lactation; female of childbearing potential not taking contraceptive measures;

    3. Patients having taken blood products including albumin products within 4 days prior to application of investigational product;

    4. Patients having participated in clinical trials of other drugs within 1 month prior to screening;

    5. Patients used to participate in clinical trials of Tolvaptan and take the said drug;

    6. Patients determined by the investigator as illegible for the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200001

    Sponsors and Collaborators

    • Otsuka Beijing Research Institute

    Investigators

    • Principal Investigator: Minde Zeng, RenJi Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01359462
    Other Study ID Numbers:
    • 156-09-806-01
    First Posted:
    May 24, 2011
    Last Update Posted:
    May 24, 2011
    Last Verified:
    May 1, 2011
    Keywords provided by , ,
    hepatic cirrhosis patients with ascites
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Fibrosis
    Ascites
    Tolvaptan

    Study Results

    No Results Posted as of May 24, 2011