Full Text View
Tabular View
No Study Results Posted
Related Studies
Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function
This study is currently recruiting participants.
Verified by Astellas Pharma Inc, April 2009
First Received: April 23, 2009   No Changes Posted
Sponsored by: Astellas Pharma Inc
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00887627
  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 96-hour continuous infusion of conivaptan.


Condition Intervention Phase
Kidney Diseases
Hyponatremia
Drug: conivaptan hydrochloride
Phase I

Drug Information available for: YM 087 Conivaptan
U.S. FDA Resources
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title: A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Measure PK and protein binding of conivaptan [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure safety and tolerability of conivaptan [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: April 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1. Mild Renal Function Impaired Subjects: Experimental Drug: conivaptan hydrochloride
intravenous
2. Moderate Renal Function Impaired Subjects: Experimental Drug: conivaptan hydrochloride
intravenous
3. Subjects with Normal Renal Function: Experimental Drug: conivaptan hydrochloride
intravenous

  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

Contacts
Contact: Astellas Pharma Global Development 800-888-7704 ext 5473 clintrials.info@us.astellas.com

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

No publications provided

Responsible Party: Astellas Pharma Global Development ( Sr Manager Clinical Trials Registry )
Study ID Numbers: 087-CL-094
Study First Received: April 23, 2009
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00887627     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Metabolic Diseases
Urologic Diseases
Hyponatremia
Water-Electrolyte Imbalance
Kidney Diseases
Metabolic Disorder

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

ClinicalTrials.gov processed this record on May 06, 2009