Pharmacokinetics of Telavancin in Normal and Obese Subjects
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Apr 2016
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 18, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedNovember 2, 2016
November 1, 2016
6 months
April 18, 2016
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Number (%) of adverse events of any severity regardless of relationship to study drug
48 hours
Area-under-the-plasma concentration-time curve (AUC0-infinity)
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
48 hours
Maximum plasma concentration (Cmax)
To estimate the telavancin pharmacokinetic parameter maximum plasma concentration (Cmax) after a single dose for intravenously dosed telavancin to healthy adult participants
48 hours
Study Arms (1)
Telavancin Administration
EXPERIMENTALSingle dose of telavancin administered as a 1-hour intravenous infusion
Interventions
A single dose of telavancin as a 1-hour intravenous infusion
Eligibility Criteria
You may qualify if:
- Healthy adult subjects, 18 to 50 years
- Nonsmokers within the last 1 year
- Weight \> 110 lbs
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Chicagolead
- Theravance Biopharmacollaborator
Study Sites (1)
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Related Publications (1)
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.
PMID: 29311094DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Keith A. Rodvold, Pharm.D.
University of Illinois at Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 18, 2016
First Posted
April 28, 2016
Study Start
April 1, 2016
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
November 2, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share