Back to resultsMultiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis
Primary Purpose
Hepatic Cirrhosis, Ascites
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
tolvaptan
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Cirrhosis focused on measuring hepatic cirrhosis patients with ascites
Eligibility Criteria
Inclusion Criteria:
- Hepatic Cirrhosis with ascites or lower extremities edema
- Hospitalized patients
- 18 years old~75 years old
- Inform Consent Form Signed
Exclusion Criteria:
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.
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.).
- Patients whose systolic blood pressure is below 90mmHg during screening;
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
- Patients ineligible for oral medication
- Patients in pregnancy or lactation; female of childbearing potential not taking contraceptive measures;
- Patients having taken blood products including albumin products within 4 days prior to application of investigational product;
- Patients having participated in clinical trials of other drugs within 1 month prior to screening;
- Patients used to participate in clinical trials of Tolvaptan and take the said drug;
- Patients determined by the investigator as illegible for the study.
Sites / Locations
- Renji Hospital, Shanghai Jiao Tong University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tolvaptan 15mg tablet
Arm Description
Outcomes
Primary Outcome Measures
Serum concentration of tolvaptan and its metabolites DM-4103 and DM-4107
Secondary Outcome Measures
pharmacological parameter:Serum concentration of sodium and potassium
pharmacological parameter:24-hr urine
Full Information
NCT ID
NCT01359462
First Posted
March 5, 2010
Last Updated
May 23, 2011
Sponsor
Otsuka Beijing Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01359462
Brief Title
Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis
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 Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Beijing Research Institute
4. Oversight
Data Monitoring Committee
No
5. 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.
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:
Open, single-center, multi-dose pharmacokinetics study
Study population:
Chinese adult patients with confirmed Child-Pugh Class B (score 7-9) hepatocirrhosis (accompanied by ascites)
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.
Study duration:
Screening: 14 days in maximum; Treatment(s): 7 days; Observation: 1 day
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Cirrhosis, Ascites
Keywords
hepatic cirrhosis patients with ascites
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tolvaptan 15mg tablet
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
tolvaptan
Other Intervention Name(s)
SAMSCA
Intervention Description
Drug: tolvaptan
tablet, 15mg, Qd, for 7 days.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
pharmacological parameter:24-hr urine
Time Frame
From day-1 to day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hepatic Cirrhosis with ascites or lower extremities edema
Hospitalized patients
18 years old~75 years old
Inform Consent Form Signed
Exclusion Criteria:
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.
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.).
Patients whose systolic blood pressure is below 90mmHg during screening;
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
Patients ineligible for oral medication
Patients in pregnancy or lactation; female of childbearing potential not taking contraceptive measures;
Patients having taken blood products including albumin products within 4 days prior to application of investigational product;
Patients having participated in clinical trials of other drugs within 1 month prior to screening;
Patients used to participate in clinical trials of Tolvaptan and take the said drug;
Patients determined by the investigator as illegible for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minde Zeng
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
12. IPD Sharing Statement
Learn more about this trial
Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis
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