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

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Diseases; End Stage Renal Disease
• Intervention / Treatment: Drug: telavancin

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal renal function; Subjects with normal renal function	Drug: telavancin; Intravenous; Other Names: TD-6424; VIBATIV®; ASP9809
Experimental: Severe renal impairment; Subjects with severe renal impairment	Drug: telavancin; Intravenous; Other Names: TD-6424; VIBATIV®; ASP9809
Experimental: End stage renal disease; Subjects with end stage renal disease	Drug: telavancin; Intravenous; Other Names: TD-6424; VIBATIV®; ASP9809

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentration of telavancin as estimated by antibiotic potency bioassay	Days 1-4
Concentration of telavancin as determined by standard Liquid Chromatography Tandem Mass Spectrometer (LC/MS/MS)	Days 1-4

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic variables through analysis of blood samples	Days 1-4

Collaborators and Investigators

• Sponsor: Cumberland Pharmaceuticals
• Investigators: Study Director: Medical Director, Cumberland Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: November 9, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (Estimate): November 11, 2010

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Pharmacokinetics; telavancin; Severe renal disease; VIBATIV®; ASP9809
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Anti-Infective Agents; Anti-Bacterial Agents; Telavancin
• Other Study ID Numbers: 9809-CL-1407