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

Phase 1

Completed

• Conditions: Renal Insufficiency, Chronic; Hepatic Insufficiency; Healthy
• Interventions: Drug: Diclofenac Sodium; Drug: Sporanox

• Registration Number: NCT00805090
• Lead Sponsor: Javelin Pharmaceuticals

Brief Summary

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®.

Detailed Description

For the renal and hepatic subjects, following the screening visit, eligible subjects will return to the study site on Study Day 0 and remain at the site for 2 nights and 2 days. Study drug administration will occur on Study Day 1. Subjects will be discharged on Study Day 2 after the last blood sample has been collected. Subjects will return 7 ± 3 days after dosing with study drug to have final safety assessments performed. For the healthy subjects, following the screening visit, eligible subjects will return to the study site on Study Day 0 and remain at the site for 3 nights and 3 days. Study drug administration will occur on Study Day 1 and Study Day 2. Subjects will be discharged on Study Day 3 after the last blood sample has been collected. Subjects will return 7 ± 3 days after receiving the last dose of study drug to have final safety assessments performed.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Primary Completion: 2009-03
• Status Verified: 2009-04
• Study Completion: 2009-04
• Last Update Submitted: 2009-04-29
• Last Update Posted: 2009-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dyloject	Diclofenac Sodium	Diclofenac Sodium
Sporanox	Sporanox	Active arm approved as an anti-fungal being used to compare HPβCD when administered in DIC075V compared to Sporanox.

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and pharmacokinetics of diclofenac and HPβCD following a single-dose of DIC075V in subjects with mild or moderate chronic renal insufficiency and in subjects with mild hepatic impairment compared to healthy adult volunteers.	Screening - Follow-up

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and pharmacokinetics of HPβCD following a single-dose of DIC075V and Sporanox in healthy adult volunteers.	Screening - Follow-up

Trial Locations

Locations (4)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Simbec Research, Ltd.; 🇬🇧 Merthyr Tydfil, United Kingdom

New Orleans Clinical Center for Research; 🇺🇸 Knoxville, Tennessee, United States

Davita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States