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

Information source: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Diseases; End Stage Renal Disease

Intervention: telavancin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Theravance Biopharma Antibiotics, Inc.

Official(s) and/or principal investigator(s):
Senior Medical Director, Study Director, Affiliation: Astellas Pharma Global Development

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.

Clinical Details

Official title: A Phase 1 Open-Label Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

Concentration of telavancin as estimated by antibiotic potency bioassay

Concentration of telavancin as determined by standard Liquid Chromatography Tandem Mass Spectrometer (LC/MS/MS)

Secondary outcome: Pharmacokinetic variables through analysis of blood samples

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Clinical Pharmacology of Miami, Miami, Florida 33014, United States

Orlando Clinical Research Center, Orlando, Florida 32809, United States

DaVita Clinical Research, Minneapolis, Minnesota 55404, United States

New Orleans Center for Clinical Research, Knoxville, Tennessee 37920, United States

Additional Information

Starting date: December 2010
Last updated: February 6, 2012

Page last updated: August 23, 2015

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