Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function

Overview

A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan.

Full Title of Study: “A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2010

Interventions

  • Drug: conivaptan hydrochloride
    • intravenous

Arms, Groups and Cohorts

  • Experimental: 1. Mild Renal Function Impaired Subjects
  • Experimental: 2. Moderate Renal Function Impaired Subjects
  • Experimental: 3. Subjects with Normal Renal Function

Clinical Trial Outcome Measures

Primary Measures

  • Measure PK and protein binding of conivaptan
    • Time Frame: 5 days

Secondary Measures

  • Measure safety and tolerability of conivaptan
    • Time Frame: 5 days

Participating in This Clinical Trial

Inclusion Criteria

  • Weighs at least 45 kg – Body mass index between 18 and 40 kg/m2 inclusive – Must be in good health other than renal function impairment and related stable diseases for the renal impaired subjects – Must have a screening and pre-dose estimated glomerular filtration rate (GFR) that corresponds with the level of renal impairment based on the abbreviated Modification of Diet in Renal Disease (MDRD) formula – Female subject of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test, utilizes adequate contraceptive methods while in this study or may be surgically sterile and/or two years post menopausal Exclusion Criteria:

  • Subject is known to be HIV positive or has HIV antibodies – Has clinically significant history or presence of illness, medical condition, or laboratory abnormality – Is Hepatitis positive – Subject with renal impairment has not been on a stable dose of concomitant medications for at least 4 weeks prior to start of study and/or dose changes are likely during the study – History of substance abuse within 6 months prior to screening – Has clinically significant history or presence of psychiatric illness, malignancy, or immunodeficiency syndrome – Has abnormal liver function tests (ALT, AST, and/or bilirubin) – Has had a blood transfusion or donated/lost more than 450ml of blood within 56 days of study drug administration or has donated plasma within 7 days prior to study drug administration

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cumberland Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Art Wheeler, MD, Study Director, Cumberland Pharmaceuticals, Inc.

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