A Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin - Full Text View

Purpose

The purpose of this study is to evaluate the effect of renal function on the biological activity of telavancin using blood samples obtained from subjects with normal renal function, severe renal impairment, and end stage renal disease.

Condition	Intervention	Phase
Kidney Diseases End Stage Renal Disease	Drug: telavancin	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	A Phase 1 Open-Label Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

Drug Information available for: Telavancin

U.S. FDA Resources

Further study details as provided by Theravance, Inc.:

Primary Outcome Measures:

Concentration of telavancin as estimated by antibiotic potency bioassay [ Time Frame: Days 1-4 ] [ Designated as safety issue: No ]
Concentration of telavancin as determined by standard Liquid Chromatography Tandem Mass Spectrometer (LC/MS/MS) [ Time Frame: Days 1-4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetic variables through analysis of blood samples [ Time Frame: Days 1-4 ] [ Designated as safety issue: No ]

Enrollment:	45
Study Start Date:	December 2010
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Normal renal function Subjects with normal renal function	Drug: telavancin Intravenous Other Names: VIBATIV® TD-6424 ASP9809
Experimental: Severe renal impairment Subjects with severe renal impairment	Drug: telavancin Intravenous Other Names: VIBATIV® TD-6424 ASP9809
Experimental: End stage renal disease Subjects with end stage renal disease	Drug: telavancin Intravenous Other Names: VIBATIV® TD-6424 ASP9809

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Weighs at least 45 kg and body mass index of 18 to 40 kg/m2, inclusive
An estimated creatinine clearance value based on Cockcroft-Gault method of:
- >80 mL/min for subjects with normal renal function
- <30 mL/min for subjects with severe renal impairment
- receiving hemodialysis three times a week for subjects with end stage renal impairment
If female, the subject is at least 2 years postmenopausal, surgically sterile or practicing effective birth control, and is not pregnant or lactating
Good venous access

Exclusion Criteria:

History of any clinically significant acute illness (other than renal disease and conditions related to the renal disease in renal impairment subjects, such as stable diabetes or hypertension)
Has had a kidney transplant that is still functioning
History of unexplained syncope, cardiac arrest, unexplained cardiac arrythmia or torsade de pointes, structural heart disease, prolonged QT interval, or family history of long QT syndrome
Known hypersensitivity to telavancin or any of the excipients in the formulation, or a history of severe allergic or anaphylactic reactions
History of consuming more than 7 units of alcoholic beverages per week, or history of alcoholism or substance abuse within past 2 years
Known to be positive for human immunodeficiency virus antibody
For subjects with normal renal function, has had treatment with prescription or non-prescription drugs, including complementary and alternative medicines or over-the counter medications, with the exception of oral contraceptives, hormone replacement therapy, daily aspirin, and occasional use of acetaminophen within the past 14 days
For subjects with renal impairment, has not been on a stable dose of concomitant medications for at least 2 weeks prior to study start or is taking any medication that would interfere with the evaluation of televancin in this study
Has received an experimental agent within 30 days or ten half-lives, whichever is longer, prior to study drug administration
Has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238796

Locations

United States, Florida
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920

Sponsors and Collaborators

Theravance, Inc.

Investigators

Study Director:

Senior Medical Director

Astellas Pharma Global Development

More Information

No publications provided

Responsible Party:	Theravance, Inc.
ClinicalTrials.gov Identifier:	NCT01238796 History of Changes
Other Study ID Numbers:	9809-CL-1407
Study First Received:	November 9, 2010
Last Updated:	February 6, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Theravance, Inc.:

telavancin
Pharmacokinetics
Severe renal disease
VIBATIV®
ASP9809

Additional relevant MeSH terms:

Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on June 17, 2013