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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01359462
First Posted: May 24, 2011
Last Update Posted: May 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Otsuka Beijing Research Institute
  Purpose
For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics, pharmacology, and safety of the drug under fasting condition.

Condition Intervention Phase
Hepatic Cirrhosis Ascites Drug: tolvaptan Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Otsuka Beijing Research Institute:

Primary Outcome Measures:
  • Serum concentration of tolvaptan and its metabolites DM-4103 and DM-4107 [ Time Frame: 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:
  • pharmacological parameter:Serum concentration of sodium and potassium [ Time Frame: 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 ]
  • pharmacological parameter:24-hr urine [ Time Frame: From day-1 to day 8 ]

Enrollment: 11
Study Start Date: April 2009
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tolvaptan 15mg tablet Drug: tolvaptan

Drug: tolvaptan

tablet, 15mg, Qd, for 7 days.

Other Name: SAMSCA

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)

  3. 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.

  4. Study duration:

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  2. 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.).
  3. Patients whose systolic blood pressure is below 90mmHg during screening;
  4. 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

  5. Patients ineligible for oral medication
  6. Patients in pregnancy or lactation; female of childbearing potential not taking contraceptive measures;
  7. Patients having taken blood products including albumin products within 4 days prior to application of investigational product;
  8. Patients having participated in clinical trials of other drugs within 1 month prior to screening;
  9. Patients used to participate in clinical trials of Tolvaptan and take the said drug;
  10. Patients determined by the investigator as illegible for the study.
  Contacts and Locations
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): NCT01359462


Locations
China, Shanghai
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
  More Information

Responsible Party: Ms. Feng Yan, Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier: NCT01359462     History of Changes
Other Study ID Numbers: 156-09-806-01
First Submitted: March 5, 2010
First Posted: May 24, 2011
Last Update Posted: May 24, 2011
Last Verified: May 2011

Keywords provided by Otsuka Beijing Research Institute:
hepatic cirrhosis patients with ascites

Additional relevant MeSH terms:
Fibrosis
Ascites
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs