Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-03-31

Brief Summary

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

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Detailed Description

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pharmacokinetic study

Conditions

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Liver Cirrhosis, Biliary

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

tigecycline

Intervention Type DRUG

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

Interventions

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tigecycline

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

Intervention Type DRUG

Other Intervention Names

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Tygacil, GAR-936

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No