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

NCT ID: NCT00805090

Last Updated: 2009-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-04-30

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.

Conditions

Renal Insufficiency, Chronic; Hepatic Insufficiency; Healthy

Keywords

Renal; Hepatic; Healthy

Study Design

• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Sporanox

Active arm approved as an anti-fungal being used to compare HPβCD when administered in DIC075V compared to Sporanox.

Group Type: ACTIVE_COMPARATOR

Sporanox

Intervention Type: DRUG

200 mg

Dyloject

Diclofenac Sodium

Group Type: EXPERIMENTAL

Diclofenac Sodium

Intervention Type: DRUG

37.5 mg

Interventions

Sporanox

200 mg

Intervention Type: DRUG

Diclofenac Sodium

37.5 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• 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.

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Javelin Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Javelin Pharmaceuticals

Principal Investigators

William Smith, MD

Role: PRINCIPAL_INVESTIGATOR

New Orleans Clinical Center for Research

Suzanne Swann, MD

Role: PRINCIPAL_INVESTIGATOR

Davita Clinical Research

Thomas Marbury, MD

Role: PRINCIPAL_INVESTIGATOR

Orlando Clinical Research Center

Salvatore Febbraro, MD

Role: PRINCIPAL_INVESTIGATOR

Simbec Research

Locations

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

Countries

United States; United Kingdom

References

Hamilton DA, Ernst CC, Kramer WG, Madden D, Lang E, Liao E, Lacouture PG, Ramaiya A, Carr DB. Pharmacokinetics of Diclofenac and Hydroxypropyl-beta-Cyclodextrin (HPbetaCD) Following Administration of Injectable HPbetaCD-Diclofenac in Subjects With Mild to Moderate Renal Insufficiency or Mild Hepatic Impairment. Clin Pharmacol Drug Dev. 2018 Feb;7(2):110-122. doi: 10.1002/cpdd.417. Epub 2017 Dec 2.

Reference Type: DERIVED

PMID: 29197175 (View on PubMed)

Other Identifiers

DFC-PK-009

Identifier Type: -

Identifier Source: org_study_id