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Pharmacokinetics of Telavancin in Normal and Obese Subjects

NCT ID: NCT02753855

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Telavancin Administration

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

Group Type EXPERIMENTAL

Telavancin

Intervention Type DRUG

A single dose of telavancin as a 1-hour intravenous infusion

Interventions

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Telavancin

A single dose of telavancin as a 1-hour intravenous infusion

Intervention Type DRUG

Other Intervention Names

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Vibativ

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Theravance Biopharma

INDUSTRY

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Keith A. Rodvold

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keith A. Rodvold, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29311094 (View on PubMed)

Other Identifiers

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TELAPK-2015

Identifier Type: -

Identifier Source: org_study_id