Healthy
Conditions
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.
Interventions
DRUGTelavancin
A single dose of telavancin as a 1-hour intravenous infusion
Sponsors
Theravance Biopharma
University of Illinois at Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed