Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Liver Cirrhosis, Biliary Clinical Trial

Official title:

Open Label, Single Dose Study Of The Pharmacokinetics Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406237
• Other study ID #: 3074A1-120
• Secondary ID: B1811005
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2006
• Last updated: April 1, 2011
• Start date: December 2006
• Est. completion date: March 2009

Study information

• Verified date: April 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with primary biliary cirrhosis (PBC)

Description:

pharmacokinetic study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and nonlactating and nonpregnant women greater than or equal to 18 years of age

• Subjects with biopsy proven primary biliary cirrhosis (PBC) disease in the asymptomatic or symptomatic phase of PBC.

• Otherwise healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results (other than those associated with PBC), vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

• Subjects with a recent increase in bilirubin, bilirubin >15 mg/dL, presence of ascites, esophageal varices, or hepatic encephalopathy.

• Any major illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study

• Any malignancy including hepatocellular carcinoma.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Cirrhosis, Biliary

Intervention

Drug:
• tigecycline
Single intravenous dose of tigecycline 50 mg, as a 30-minute infusion

Locations

Country	Name	City	State
Puerto Rico	Pfizer Investigational Site	Santurce
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction.		5 days	No
Secondary	To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction.		15 days	Yes

External Links

•   To obtain contact information for a study center near you, click here.