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

NCT ID: NCT01238796

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-02-28

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Normal renal function

Subjects with normal renal function

Group Type: EXPERIMENTAL

telavancin

Intervention Type: DRUG

Intravenous

Severe renal impairment

Subjects with severe renal impairment

Group Type: EXPERIMENTAL

telavancin

Intervention Type: DRUG

Intravenous

End stage renal disease

Subjects with end stage renal disease

Group Type: EXPERIMENTAL

telavancin

Intervention Type: DRUG

Intravenous

Interventions

telavancin

Intravenous

Intervention Type: DRUG

Other Intervention Names

VIBATIV®; TD-6424; ASP9809

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Cumberland Pharmaceuticals, Inc.

Locations

Clinical Pharmacology of Miami

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

DaVita Clinical Research

Minneapolis, Minnesota, United States

New Orleans Center for Clinical Research

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

9809-CL-1407

Identifier Type: -

Identifier Source: org_study_id