Anaheim, California, 92801, United States
NCT Number: NCT00887627
Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function
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.
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Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
conivaptan hydrochloride
Drugintravenous
Other names: Vaprisol, YM087
Primary outcomes
-
Measure PK and protein binding of conivaptan
Time frame: 5 days
Secondary outcomes
-
Measure safety and tolerability of conivaptan
Time frame: 5 days
Sponsors and collaborators
Lead sponsor
Cumberland Pharmaceuticals
Industry
Registry information
Official study title
A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan
Important dates
- Study start
- 2009
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Apr 24, 2009
- Registry last updated
- May 2, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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