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

NCT00805090 | Completed Phase 1

• 1 other identifier: DFC-PK-009
• Study Type: interventional
• Target: 37
• Locations: 2 countries
• Sites: 4

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®.

Conditions

Renal Insufficiency, Chronic; Hepatic Insufficiency; Healthy

Keywords

Renal; Hepatic; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate the safety and pharmacokinetics of HPβCD following a single-dose of DIC075V and Sporanox in healthy adult volunteers.

  Screening - Follow-up

Study Arms (2)

Sporanox

ACTIVE COMPARATOR

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

Drug: Sporanox

Dyloject

EXPERIMENTAL

Diclofenac Sodium

Drug: Diclofenac Sodium

Interventions

Sporanox DRUG

200 mg

Sporanox

Diclofenac Sodium DRUG

37.5 mg

Dyloject

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Javelin Pharmaceuticals: lead

Study Sites (4)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Davita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

New Orleans Clinical Center for Research

Knoxville, Tennessee, 37920, United States

Location

Simbec Research, Ltd.

Merthyr Tydfil, CF48 4DR, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29197175 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hepatic Insufficiency

Interventions

Itraconazole; Diclofenac

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 30, 2009

Record last verified: 2009-04

Locations

GB (1); US (3)