Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

NCT00406237 | Completed Phase 1

• 2 other identifiers: 3074A1-120B1811005
• Study Type: interventional
• Target: 8
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Liver Cirrhosis, Biliary

Outcome Measures

Primary Outcomes (1)

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

  5 days

Secondary Outcomes (1)

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

  15 days

Study Arms (1)

1

EXPERIMENTAL

Drug: tigecycline

Interventions

tigecycline DRUG

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

Also known as: Tygacil, GAR-936

1

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Pfizer Investigational Site

Saint Paul, Minnesota, 55114, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27710, United States

Location

Pfizer Investigational Site

Santurce, Puerto Rico, 00909, Puerto Rico

Location

Related Links

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

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: December 4, 2006
• Study Start: December 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 4, 2011

Record last verified: 2011-04

Locations

US (2); PR (1)