Clinical trial NCT02753855: Pharmacokinetics of Telavancin in Normal and Obese Subjects
Official title: Pharmacokinetics of Telavancin in Normal and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Theravance Biopharma
First posted: 2016-04-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility 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

Primary outcomes:
measure: Number (%) of adverse events of any severity regardless of relationship to study drug
timeFrame: 48 hours
measure: Area-under-the-plasma concentration-time curve (AUC0-infinity)
timeFrame: 48 hours
measure: Maximum plasma concentration (Cmax)
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Keith A. Rodvold, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bunnell KL, Pai MP, Sikka M, Bleasdale SC, Wenzler E, Danziger LH, Rodvold KA. Pharmacokinetics of Telavancin at Fixed Doses in Normal-Body-Weight and Obese (Classes I, II, and III) Adult Subjects. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02475-17. doi: 10.1128/AAC.02475-17. Print 2018 Apr.