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Telavancin

Phase 1

Healthy | Small molecule | Other |Theravance Biopharma, Inc.|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Telavancin · 1 trial · 1 indication

Phase 1 1
NCT02753855Pharmacokinetics of Telavancin in Normal and Obese SubjectsHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
Pharmacokinetics of Telavancin in Normal and Obese Subjects
Healthy
NCT0275385532
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Study Endpoints

Primary Endpoints

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

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

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
Telavancin AdministrationEXPERIMENTALSingle dose of telavancin administered as a 1-hour intravenous infusion

Interventions

NameTypeDescription
TelavancinDRUGA single dose of telavancin as a 1-hour intravenous infusion
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 *...

Countries:United States
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Frequently asked questions about Telavancin

What is Telavancin used for?

Telavancin is an investigational small molecule being studied for use in healthy subjects. It is currently in Phase 1 clinical development, with a completed trial evaluating its pharmacokinetics in normal and obese individuals. Telavancin is not approved for any indication and remains under investigation.

Who makes Telavancin?

Telavancin is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TBPH. The company is conducting clinical research to evaluate the drug's properties in healthy volunteers.

What phase is Telavancin in?

Telavancin is in Phase 1 clinical development. A single Phase 1 trial has been completed, which studied the drug's pharmacokinetics in normal and obese healthy subjects. Telavancin is investigational and has not received FDA approval.

What clinical trials is Telavancin in?

Telavancin has one completed clinical trial, NCT02753855, titled 'Pharmacokinetics of Telavancin in Normal and Obese Subjects.' This Phase 1 study enrolled 32 healthy participants in the United States and evaluated the drug's pharmacokinetic profile.

Is Telavancin FDA approved?

Telavancin is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT02753855, was a pharmacokinetic study in healthy subjects, and the drug has not yet progressed to later-stage trials or regulatory approval.