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

This study has been completed.
Information provided by:
Otsuka Beijing Research Institute Identifier:
First received: March 5, 2010
Last updated: May 23, 2011
Last verified: May 2011

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
Drug: tolvaptan
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • pharmacological parameter:24-hr urine [ Time Frame: From day-1 to day 8 ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  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
Please refer to this study by its identifier: NCT01359462

China, Shanghai
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200001
Sponsors and Collaborators
Otsuka Beijing Research Institute
Principal Investigator: Minde Zeng Renji hospital, Shanghai Jiaotong University School of Medicine
  More Information

No publications provided

Responsible Party: Ms. Feng Yan, Otsuka Beijing Research Institute Identifier: NCT01359462     History of Changes
Other Study ID Numbers: 156-09-806-01
Study First Received: March 5, 2010
Last Updated: May 23, 2011
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases processed this record on April 17, 2014