Status:
COMPLETED
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
Lead Sponsor:
Javelin Pharmaceuticals
Conditions:
Renal Insufficiency, Chronic
Hepatic Insufficiency
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 impairme...
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 administrat...
Eligibility Criteria
Inclusion
- Inclusion Criteria (General):
- The subjects must be males or females and ≥ 18 years of age and ≤ 65 years.
- The subject must be willing and able to provide signed informed consent.
- The subject must be willing and able to stay at the clinical site for the required number of days and nights and return to the clinic in 7 ± 3 days after dosing with study drug.
- Inclusion Criteria (subjects with mild or moderate chronic renal insufficiency):
- The subject must have mild or moderate chronic renal insufficiency and documented history of stable renal disease for 1 month prior to screening and clinical laboratory test results consistent with the underlying disease for renal impairment.
- Inclusion Criteria (subjects with mild chronic hepatic impairment):
- The subject must have mild chronic hepatic impairment, as defined by Child-Pugh Classification A, Score of 5-6 and a bilirubin of ≤ 2.5 mg/dl.
- Inclusion Criteria (for healthy subjects):
- Healthy subjects will be matched to renally impaired subjects in this study by age (+ 10 years), gender, and body weight (± 10 kg).
- 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).
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00805090
Start Date
December 1 2008
End Date
April 1 2009
Last Update
April 30 2009
Active Locations (4)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
2
Davita Clinical Research
Minneapolis, Minnesota, United States, 55404
3
New Orleans Clinical Center for Research
Knoxville, Tennessee, United States, 37920
4
Simbec Research, Ltd.
Merthyr Tydfil, United Kingdom, CF48 4DR