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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2009-04-30

No results posted yet for this study

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

Interventions

DRUG

Sporanox

200 mg

DRUG

Diclofenac Sodium

37.5 mg

Sponsors & Collaborators

  • Javelin Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • William Smith, MD · New Orleans Clinical Center for Research

  • Suzanne Swann, MD · Davita Clinical Research

  • Thomas Marbury, MD · Orlando Clinical Research Center

  • Salvatore Febbraro, MD · Simbec Research

Study Design

Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-03-31
Completion
2009-04-30

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00805090 on ClinicalTrials.gov