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 - Full Text View

Sponsor:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00805090

Purpose

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®.

Condition	Intervention	Phase
Renal Insufficiency, Chronic Hepatic Insufficiency Healthy	Drug: Sporanox Drug: Diclofenac Sodium	Phase I

Study Type:	Interventional
Study Design:	Open Label, Active Control, Crossover Assignment, Safety Study
Official Title:	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.

Resource links provided by NLM:

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Itraconazole

U.S. FDA Resources

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	37
Study Start Date:	December 2008
Study Completion Date:	April 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sporanox: Active Comparator Active arm approved as an anti-fungal being used to compare HPβCD when administered in DIC075V compared to Sporanox.	Drug: Sporanox 200 mg
Dyloject: Experimental Diclofenac Sodium	Drug: Diclofenac Sodium 37.5 mg

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805090

Locations

United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Minnesota
Davita Clinical Research
Minneapolis, Minnesota, United States, 55404
United States, Tennessee
New Orleans Clinical Center for Research
Knoxville, Tennessee, United States, 37920
United Kingdom
Simbec Research, Ltd.
Merthyr Tydfil, United Kingdom, CF48 4DR

Sponsors and Collaborators

Javelin Pharmaceuticals

Investigators

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, Ltd.

More Information

No publications provided

Responsible Party:	Javelin Pharmaceuticals ( Cynthia Ernst )
Study ID Numbers:	DFC-PK-009
Study First Received:	December 8, 2008
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00805090 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Javelin Pharmaceuticals:

Renal
Hepatic
Healthy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Antiprotozoal Agents
Liver Diseases
Renal Insufficiency
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hydroxyitraconazole
Itraconazole
Antiparasitic Agents
Urologic Diseases
Sensory System Agents
Therapeutic Uses
Antifungal Agents

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Kidney Diseases
Hepatic Insufficiency
Cyclooxygenase Inhibitors
Diclofenac
Enzyme Inhibitors
Pharmacologic Actions
Digestive System Diseases
Analgesics, Non-Narcotic
Renal Insufficiency, Chronic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010