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Completed

NCT Number: NCT00406237

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 (PBC)

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Key information

Conditions

Liver Cirrhosis, Biliary Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Santurce, Puerto Rico

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About this study

pharmacokinetic study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tigecycline

Drug

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

Other names: Tygacil, GAR-936

Primary outcomes

  1. To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction.

    Time frame: 5 days

Secondary outcomes

  1. To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction.

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 4, 2006
Registry last updated
Apr 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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