Pharmacokinetics of Telavancin in Normal and Obese Subjects

University of Illinois

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Telavancin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02753855

TELAPK-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

32 participants in 1 patient group

Telavancin Administration

Experimental group

Description:

Single dose of telavancin administered as a 1-hour intravenous infusion

Treatment:

Drug: Telavancin