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OpenTrials
Completed

NCT Number: NCT00851227

Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function

A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Miami, Florida, 33014, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects with Normal Hepatic Function:
  • Weighs at least 45 kg
  • Body mass index between 18 and 40 kg/m2 inclusive
  • Must have normal hepatic function
  • Hepatic Impaired Subjects:
  • Weighs at least 45 kg
  • Meets criteria for mild or moderate hepatic impairment defined by Child-Pugh method
  • Body mass index between 18 and 40 kg/m2 inclusive

Exclusion criteria

  • Subjects with Normal Hepatic Function:
  • Smokes more than 10 cigarettes per day
  • Known to be HIV positive or has HIV antibodies
  • Has clinically significant history or presence of illness, malignancy, or immunodeficiency
  • Is Hepatitis A, B, or C positive
  • Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration
  • History of substance abuse within 6 months prior to screening
  • Hepatic Impaired Subjects:
  • Has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced acidities, portal hypertension, or biliary liver cirrhosis
  • Is hypovolemic or has evidence of orthostatic hypotension
  • Smokes more than 10 cigarettes per day
  • Known to be HIV positive or has HIV antibodies
  • Has clinically significant history or presence of illness, malignancy, or immunodeficiency
  • Has clinically significant history or presence of GI symptoms other than those associated with moderate hepatic impairment
  • Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration
  • History of substance abuse within 6 months prior to screening

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 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 Effect of Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 25, 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.

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