A Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01238796
Recruitment Status : Completed
First Posted : November 11, 2010
Last Update Posted : February 8, 2012
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Diseases End Stage Renal Disease Drug: telavancin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Phase 1 Open-Label Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin
Study Start Date : December 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Normal renal function
Subjects with normal renal function
Drug: telavancin
Other Names:
  • TD-6424
  • ASP9809
Experimental: Severe renal impairment
Subjects with severe renal impairment
Drug: telavancin
Other Names:
  • TD-6424
  • ASP9809
Experimental: End stage renal disease
Subjects with end stage renal disease
Drug: telavancin
Other Names:
  • TD-6424
  • ASP9809

Primary Outcome Measures :
  1. Concentration of telavancin as estimated by antibiotic potency bioassay [ Time Frame: Days 1-4 ]
  2. Concentration of telavancin as determined by standard Liquid Chromatography Tandem Mass Spectrometer (LC/MS/MS) [ Time Frame: Days 1-4 ]

Secondary Outcome Measures :
  1. Pharmacokinetic variables through analysis of blood samples [ Time Frame: Days 1-4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01238796

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 Biopharma Antibiotics, Inc.
Study Director: Senior Medical Director Astellas Pharma Global Development

Responsible Party: Theravance Biopharma Antibiotics, Inc. Identifier: NCT01238796     History of Changes
Other Study ID Numbers: 9809-CL-1407
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
Severe renal disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Anti-Bacterial Agents
Anti-Infective Agents