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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier:
NCT01238796
First received: November 9, 2010
Last updated: February 6, 2012
Last verified: February 2012
  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:


Further study details as provided by Theravance Biopharma Antibiotics, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Theravance Biopharma Antibiotics, 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 Biopharma Antibiotics, Inc.:
telavancin
Pharmacokinetics
Severe renal disease
VIBATIV®
ASP9809

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Telavancin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014