Pharmacokinetics of Telavancin in Normal and Obese Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Telavancin

• Registration Number: NCT02753855
• Lead Sponsor: University of Illinois at Chicago

Brief 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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-28
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telavancin Administration	Telavancin	Single dose of telavancin administered as a 1-hour intravenous infusion

Primary Outcome Measures

Name	Time	Method
Number (%) of adverse events of any severity regardless of relationship to study drug	48 hours
Area-under-the-plasma concentration-time curve (AUC0-infinity)	48 hours	To estimate the telavancin pharmacokinetic parameter area-under-the-plasma concentration-time curve (AUC0-infinity) after a single dose of telavancin in healthy adult participants
Maximum plasma concentration (Cmax)	48 hours	To estimate the telavancin pharmacokinetic parameter maximum plasma concentration (Cmax) after a single dose for intravenously dosed telavancin to healthy adult participants

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States