Healthy volunteer DIC075V and Sporanox crossover PK study

• Research type

  Research Study

• Full 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 patients 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 HPßCD when administered in DIC075V compared to Sporanox® in healthy adult volunteers.

• IRAS ID

  8957

• Sponsor organisation

  Javelin Pharmaceuticals, Inc.

• Eudract number

  2008-008178-29

• Clinicaltrials.gov Identifier

  NCT00805090

• Research summary

  DIC075V (diclofenac sodium) is an injectable non-steroidal anti-inflammatory drug (NSAID) currently under investigation as a 75mg/2ml injection. NSAIDs produce pain relief that is often equivalent to that seen after opioid administration, without the typical opioid-associated side effects of sedation and respiratory depression. Injectable NSAIDs may be particularly useful in outpatient surgical procedures where a rapid recovery is desirable, in critically ill patients requiring analgesia without opioid side effects, and in patients who are not able to tolerate oral formulations. The injectable formulation affords a rapid onset of action and circumvents first-pass metabolic elimination effects.Historically, diclofenac has been applied for the management of inflammatory and degenerative forms of osteoarthritis, painful musculoskeletal conditions, and acute attacks of gout, painful post-operative and post-traumatic inflammation and pain. The drug has been available worldwide in delayed release enteric-coated tablets, sustained release tablets, suppositories, and ampoules of injectable diclofenac for intravenous and intramuscular injection.Diclofenac sodium for injection has established itself outside of the United States as an appropriate therapeutic choice for a variety of painful conditions and may be the NSAID of choice in some specific situations. Diclofenac sodium for injection has been evaluated for the relief of acute pain following a variety of procedures and conditions e.g., laparoscopy, laparotomy, thoracotomy, joint replacement, cancer, tonsillectomy, etc. Diclofenac sodium has been shown to be pharmacodynamically equivalent to the combination of opioids and spasmolytics, with better tolerability compared with high doses of opioids and significant opioid-sparing effects. DIC075V has a necessary additive called Hydroxypropyl-ǟ÷-cyclodextrin (HPǟ÷CD) which is a solubilizing agent, allowing the drug to be given in an injection of a small volume.In the healthy volunteer portion of this study, the only part of the study being conducted in the UK, the safety and pharmacodynamics of the DIC075V and the HPǟ÷CD additive are being compared. The healthy volunteers will be administered the DIC075V and Sporanox (which also has the HPǟ÷CD additive) medications on consecutive days and timed blood sampling carried out. This will provide data for the blood levels of both the DIC075V medication and HPǟ÷CD additive when the DIC075V is administered and the HPǟ÷CD additive when the Sporanox is administered.

• REC name

  Wales REC 2

• REC reference

  09/WSE02/1

• Date of REC Opinion

  15 Jan 2009

• REC opinion

  Favourable Opinion