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

NCT01359462 | Completed Phase 1

• 1 other identifier: 156-09-806-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatic Cirrhosis; Ascites

Keywords

hepatic cirrhosis patients with ascites

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• 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

• pharmacological parameter:24-hr urine

  From day-1 to day 8

Study Arms (1)

Tolvaptan 15mg tablet

EXPERIMENTAL

Drug: tolvaptan

Interventions

tolvaptan DRUG

Drug: tolvaptan tablet, 15mg, Qd, for 7 days.

Also known as: SAMSCA

Tolvaptan 15mg tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hepatic Cirrhosis with ascites or lower extremities edema
• Hospitalized patients
• years old\~75 years old
• Inform Consent Form Signed

You may not qualify if:

• 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:

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200001, China

Location

Related Publications (1)

• Liu H, Wang Y, Liu T, Chen Y, Zheng X, Liu M, Zhao Q, Zeng M, Jiang J, Mao Y, Hu P. Pharmacokinetics, pharmacodynamics and safety of 15 mg-tolvaptan administered orally for 7 consecutive days to Chinese patients with child-Pugh B cirrhosis. Front Pharmacol. 2024 Jan 26;15:1324299. doi: 10.3389/fphar.2024.1324299. eCollection 2024.

  PMID: 38344178 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Ascites

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Minde Zeng

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: May 24, 2011
• Study Start: April 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: January 1, 2010
• Last Updated: May 24, 2011

Record last verified: 2011-05

Locations

CN (1)