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

This study has been completed.
Sponsor:
Information provided by:
Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00805090
First received: December 8, 2008
Last updated: April 29, 2009
Last verified: April 2009

December 8, 2008
April 29, 2009
December 2008
March 2009   (final data collection date for primary outcome measure)
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. [ Time Frame: Screening - Follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00805090 on ClinicalTrials.gov Archive Site
To evaluate the safety and pharmacokinetics of HPβCD following a single-dose of DIC075V and Sporanox in healthy adult volunteers. [ Time Frame: Screening - Follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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 Subjects With Mild Chronic Hepatic Impairment Compared to Healthy Adult Volunteers and a Randomized, Open-Label, Single-Dose, Two-Way, Crossover Study to Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Adult Volunteers.

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®.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Renal Insufficiency, Chronic
  • Hepatic Insufficiency
  • Healthy
  • Drug: Sporanox
    200 mg
  • Drug: Diclofenac Sodium
    37.5 mg
  • Active Comparator: Sporanox
    Active arm approved as an anti-fungal being used to compare HPβCD when administered in DIC075V compared to Sporanox.
    Intervention: Drug: Sporanox
  • Experimental: Dyloject
    Diclofenac Sodium
    Intervention: Drug: Diclofenac Sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
April 2009
March 2009   (final data collection date for primary outcome measure)

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).
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00805090
DFC-PK-009
No
Cynthia Ernst, Javelin Pharmaceuticals
Javelin Pharmaceuticals
Not Provided
Principal Investigator: William Smith, MD New Orleans Clinical Center for Research
Principal Investigator: Suzanne Swann, MD Davita Clinical Research
Principal Investigator: Thomas Marbury, MD Orlando Clinical Research Center
Principal Investigator: Salvatore Febbraro, MD Simbec Research
Javelin Pharmaceuticals
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP