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Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

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Wyeth

Status and phase

Completed
Phase 1

Conditions

Liver Cirrhosis, Biliary

Treatments

Drug: tigecycline

Study type

Interventional

Funder types

Industry

Identifiers

NCT00406237
B1811005
3074A1-120

Details and patient eligibility

About

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

Full description

pharmacokinetic study

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

8 participants in 1 patient group

1
Experimental group
Treatment:
Drug: tigecycline

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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