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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00851227
Other study ID # 087-CL-086
Secondary ID
Status Completed
Phase Phase 1
First received February 23, 2009
Last updated April 30, 2014
Start date February 2009
Est. completion date January 2010

Study information

Verified date April 2014
Source Cumberland Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 70 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
conivaptan hydrochloride
intravenous

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure PK and protein binding of conivaptan 5 days No
Secondary Measure tolerability of conivaptan 5 days No
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