Pharmacokinetics of Telavancin in Normal and Obese Subjects
November 1, 2016 updated by: Keith A. Rodvold, University of Illinois at Chicago
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telavancin Administration
Single dose of telavancin administered as a 1-hour intravenous infusion
|
A single dose of telavancin as a 1-hour intravenous infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number (%) of adverse events of any severity regardless of relationship to study drug
Time Frame: 48 hours
|
48 hours
|
|
|
Area-under-the-plasma concentration-time curve (AUC0-infinity)
Time Frame: 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
|
48 hours
|
|
Maximum plasma concentration (Cmax)
Time Frame: 48 hours
|
To estimate the telavancin pharmacokinetic parameter maximum plasma concentration (Cmax) after a single dose for intravenously dosed telavancin to healthy adult participants
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Keith A. Rodvold, Pharm.D., University of Illinois at Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
April 18, 2016
First Submitted That Met QC Criteria
April 26, 2016
First Posted (Estimate)
April 28, 2016
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TELAPK-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.