- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00887627
Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function
April 30, 2014 updated by: Cumberland Pharmaceuticals
A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Anaheim, California, United States, 92801
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1. Mild Renal Function Impaired Subjects
|
intravenous
Other Names:
|
Experimental: 2. Moderate Renal Function Impaired Subjects
|
intravenous
Other Names:
|
Experimental: 3. Subjects with Normal Renal Function
|
intravenous
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure PK and protein binding of conivaptan
Time Frame: 5 days
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure safety and tolerability of conivaptan
Time Frame: 5 days
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Art Wheeler, MD, Cumberland Pharmaceuticals, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
April 23, 2009
First Submitted That Met QC Criteria
April 23, 2009
First Posted (Estimate)
April 24, 2009
Study Record Updates
Last Update Posted (Estimate)
May 2, 2014
Last Update Submitted That Met QC Criteria
April 30, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 087-CL-094
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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