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

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ClinicalTrials.gov Identifier: NCT00887627
Recruitment Status : Completed
First Posted : April 24, 2009
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Kidney Diseases Hyponatremia Drug: conivaptan hydrochloride Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan
Study Start Date : April 2009
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1. Mild Renal Function Impaired Subjects Drug: conivaptan hydrochloride
intravenous
Other Names:
  • Vaprisol
  • YM087
Experimental: 2. Moderate Renal Function Impaired Subjects Drug: conivaptan hydrochloride
intravenous
Other Names:
  • Vaprisol
  • YM087
Experimental: 3. Subjects with Normal Renal Function Drug: conivaptan hydrochloride
intravenous
Other Names:
  • Vaprisol
  • YM087


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

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): NCT00887627


Locations
United States, California
Anaheim, California, United States, 92801
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals Inc.
More Information

Additional Information:
Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00887627     History of Changes
Other Study ID Numbers: 087-CL-094
First Posted: April 24, 2009    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014

Keywords provided by Cumberland Pharmaceuticals:
Pharmacokinetics
Protein Binding
Conivaptan
Vaprisol
Kidney Diseases

Additional relevant MeSH terms:
Kidney Diseases
Hyponatremia
Urologic Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Conivaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs