Pharmacokinetics of Telavancin in Normal and Obese Subjects

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to characterize plasma and urinary concentrations of telavancin following intravenous administration of a single dose of telavancin in healthy subjects who are normal weight, overweight, and obese.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Illinois at Chicago
• Collaborators: Theravance Biopharma; Theravance Biopharma Antibiotics, Inc.
• Treatments: Telavancin

Criteria

Inclusion Criteria:

• Healthy adult subjects, 18 to 50 years

• Nonsmokers within the last 1 year

• Weight > 110 lbs

Exclusion Criteria:

• History of significant hypersensitivity reaction or intolerance to telavancin

• Aspartate or alanine aminotransferase > 1.5 times the upper limit of normal

• Estimated creatinine clearance <60 mL/minute and serum creatinine >1.5 mg/dL

• Female subjects who are pregnant or breast feeding

• History of alcohol or substance abuse or dependence within the last 1 year

• Use of prescription or nonprescription drugs (unless hormonal contraceptives) within 7 to 14 days prior to telavancin administration

• Participation in a clinical trials within last 30 days

• Donated blood (>500 mL) within the last 56 days