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

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ClinicalTrials.gov Identifier: NCT00851227
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Liver Disease Hyponatremia Drug: conivaptan hydrochloride Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Open-Label Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
Study Start Date : February 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1. Mildly Hepatic Impaired Subjects Drug: conivaptan hydrochloride
intravenous
Other Names:
  • Vaprisol
  • YM087

Experimental: 2. Moderately Hepatic Impaired Subjects Drug: conivaptan hydrochloride
intravenous
Other Names:
  • Vaprisol
  • YM087

Experimental: 3. Subjects with Normal Hepatic Function Drug: conivaptan hydrochloride
intravenous
Other Names:
  • Vaprisol
  • YM087




Primary Outcome Measures :
  1. Measure PK and protein binding of conivaptan [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Measure tolerability of conivaptan [ Time Frame: 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851227


Locations
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United States, Florida
Miami, Florida, United States, 33014
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
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Study Director: Art Wheeler, MD Cumberland Pharmaceuticals, Inc.

Additional Information:
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Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00851227     History of Changes
Other Study ID Numbers: 087-CL-086
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014
Keywords provided by Cumberland Pharmaceuticals:
Pharmacokinetics
Protein Binding
Conivaptan
Vaprisol
Liver Disease
Additional relevant MeSH terms:
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Liver Diseases
Hyponatremia
Digestive System Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Conivaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs