Skip to main content
OpenTrials
Completed

NCT Number: NCT00887627

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conivaptan hydrochloride

Drug

intravenous

Other names: Vaprisol, YM087

Primary outcomes

  1. Measure PK and protein binding of conivaptan

    Time frame: 5 days

Secondary outcomes

  1. Measure safety and tolerability of conivaptan

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 24, 2009
Registry last updated
May 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.