Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

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

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

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis, Biliary
• Intervention / Treatment: Drug: tigecycline

Detailed Description

pharmacokinetic study

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Puerto Rico
  • Santurce, Puerto Rico, 00909
    • Pfizer Investigational Site
• United States
  • Minnesota
    • St. Paul, Minnesota, United States, 55114
      • Pfizer Investigational Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: tigecycline; Single intravenous dose of tigecycline 50 mg, as a 30-minute infusion; Other Names: Tygacil, GAR-936

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction.	5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction.	15 days

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: November 29, 2006
• First Submitted That Met QC Criteria: November 30, 2006
• First Posted (Estimate): December 4, 2006

Study Record Updates

• Last Update Posted (Estimate): April 4, 2011
• Last Update Submitted That Met QC Criteria: April 1, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Fibrosis; Liver Cirrhosis; Liver Cirrhosis, Biliary; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Tigecycline
• Other Study ID Numbers: 3074A1-120; B1811005