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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00887627
First received: April 23, 2009
Last updated: February 26, 2013
Last verified: July 2010
History of Changes
  Purpose

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 Intervention Phase
Kidney Diseases
Hyponatremia
 Drug: conivaptan hydrochloride
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Measure PK and protein binding of conivaptan [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure safety and tolerability of conivaptan [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: April 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887627

Locations
United States, California
Anaheim, California, United States, 92801
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Global Development
  More Information

Additional Information:
Link to results on JAPIC  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00887627     History of Changes
Other Study ID Numbers: 087-CL-094
Study First Received: April 23, 2009
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Pharmacokinetics
Protein Binding
Conivaptan
Vaprisol
Kidney Diseases

Additional relevant MeSH terms:
Hyponatremia
Kidney Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013