Miami, Florida, 33014, United States
NCT Number: NCT00851227
Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function
A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function
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Notify MeKey information
Conditions
Age range
30 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
- Subjects with Normal Hepatic Function:
- Weighs at least 45 kg
- Body mass index between 18 and 40 kg/m2 inclusive
- Must have normal hepatic function
- Hepatic Impaired Subjects:
- Weighs at least 45 kg
- Meets criteria for mild or moderate hepatic impairment defined by Child-Pugh method
- Body mass index between 18 and 40 kg/m2 inclusive
Exclusion criteria
- Subjects with Normal Hepatic Function:
- Smokes more than 10 cigarettes per day
- Known to be HIV positive or has HIV antibodies
- Has clinically significant history or presence of illness, malignancy, or immunodeficiency
- Is Hepatitis A, B, or C positive
- Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration
- History of substance abuse within 6 months prior to screening
- Hepatic Impaired Subjects:
- Has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced acidities, portal hypertension, or biliary liver cirrhosis
- Is hypovolemic or has evidence of orthostatic hypotension
- Smokes more than 10 cigarettes per day
- Known to be HIV positive or has HIV antibodies
- Has clinically significant history or presence of illness, malignancy, or immunodeficiency
- Has clinically significant history or presence of GI symptoms other than those associated with moderate hepatic impairment
- Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration
- History of substance abuse within 6 months prior to screening
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 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 Effect of Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
Important dates
- Study start
- 2009
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Feb 25, 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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