NCT02753855

Pharmacokinetics of Telavancin in Normal and Obese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a Phase I, open-label, single-dose pharmacokinetic study in healthy adult male and female subjects. Eligible subjects will be assigned to one of four groups based on their body mass index and total body weight. Subjects will receive a single dose of telavancin depending on subject's group as a 1-hour intravenous infusion. Serial blood and urine samples will be collected over 12 hours to determine serum and urinary pharmacokinetics of telavancin. Subjects will return for blood and urine sample collection at 24 and 48 hours. Safety evaluations will be assessed throughout the study and will include physical examination, vital sign monitoring, clinical laboratory tests, monitoring of adverse events, and markers of kidney injury.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Telavancin	A single dose of telavancin as a 1-hour intravenous infusion

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-04-28
• Last updated: 2016-11-02

Locations

1 site across 1 country: United States