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

NCT01238796 | Completed Phase 1

• 1 other identifier: 9809-CL-1407
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

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.

Conditions

Kidney Diseases; End Stage Renal Disease

Keywords

telavancin; Pharmacokinetics; Severe renal disease; VIBATIV®; ASP9809

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pharmacokinetic variables through analysis of blood samples

  Days 1-4

Study Arms (3)

Normal renal function

EXPERIMENTAL

Subjects with normal renal function

Drug: telavancin

Severe renal impairment

EXPERIMENTAL

Subjects with severe renal impairment

Drug: telavancin

End stage renal disease

EXPERIMENTAL

Subjects with end stage renal disease

Drug: telavancin

Interventions

telavancin DRUG

Intravenous

Also known as: VIBATIV®, TD-6424, ASP9809

End stage renal disease; Normal renal function; Severe renal impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (4)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

New Orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic

Interventions

telavancin

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Cumberland Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 11, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

US (4)