Clincosm LogoSign in Get a demo

Pharmacokinetics of Telavancin in Normal and Obese Subjects

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT02753855
Collaborator
Theravance Biopharma (Industry)
32
Enrollment
1
Location
1
Arm
6
Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Pharmacokinetics of Telavancin in Normal and Obese Subjects
Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telavancin Administration

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

Drug: Telavancin
A single dose of telavancin as a 1-hour intravenous infusion
Other Names:
  • Vibativ

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number (%) of adverse events of any severity regardless of relationship to study drug [48 hours]

    2. 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

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Illinois at Chicago Chicago Illinois United States 60612

    Sponsors and Collaborators

    • University of Illinois at Chicago
    • Theravance Biopharma

    Investigators

    • Principal Investigator: Keith A. Rodvold, Pharm.D., University of Illinois at Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Keith A. Rodvold, Professor, University of Illinois at Chicago
    ClinicalTrials.gov Identifier:
    NCT02753855
    Other Study ID Numbers:
    • TELAPK-2015
    First Posted:
    Apr 28, 2016
    Last Update Posted:
    Nov 2, 2016
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Telavancin

    Study Results

    No Results Posted as of Nov 2, 2016