Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects

Completed · Phase 1

Conditions studied: Renal Insufficiency, Chronic, Hepatic Insufficiency, Healthy

In brief

An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic hepatic impairment compared. Additionally, the healthy adult volunteers will participate in a randomized, open-label, crossover study in which they will receive Sporanox® to compare the safety and pharmacokinetics of HPβCD when administered in DIC075V compared to Sporanox®.

Key facts

Study ID

NCT00805090

Run by

Javelin Pharmaceuticals

People needed

37

Starts

2008-12-01

Expected to finish

2009-04-01

Last updated by the study team

2009-04-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• The subject has a known allergy or hypersensitivity to diclofenac, other NSAIDs, any of the excipients of the study preparation (hydroxypropyl-ß-cyclodextrin (HPßCD), monothioglycerol, sodium hydroxide, hydrochloric acid, and water for injection), itraconzaole or other "azole" drugs, or to any of the excipients in Sporanox (HPßCD, propylene glycol, sodium hydroxide, hydrochloric acid, or water for injection).

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States
• Davita Clinical Research — Minneapolis, Minnesota, United States
• New Orleans Clinical Center for Research — Knoxville, Tennessee, United States
• Simbec Research, Ltd. — Merthyr Tydfil, United Kingdom

Full record on ClinicalTrials.gov

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