PRC-4016 - Drug interaction Study

• Research type

  Research Study

• Full title

  A Phase I, Open Label Study to Assess the Effects of PRC-4016 (Icosabutate) on the Pharmacokinetics of Midazolam, Omeprazole, Flurbiprofen and Simvastatin in Healthy Male/Female Subjects

• IRAS ID

  161017

• Sponsor organisation

  Pronova BioPharma Norge AS

• Eudract number

  2014-002898-11

• Research summary

  Pronova BioPharma Norge AS is developing PRC 4016, a novel, orally administered, highly potent, structurally enhanced fatty acid for the treatment of dyslipidaemia (abnormality in blood cholesterol level).
  PRC 4016 contains the drug substance PRB 01022 (Icosabutate). In animal and human studies Icosabutate has demonstrated reductions in blood cholesterol.
  In clincial studies there were no clinically relevant changes in any of the safety parameters evaluated, including vital signs, ECG, physical examinations and laboratory safety assessments.
  This is a drug interaction study. We will be assessing if PRB 01022 affects the way that the body handles certain drugs when they are given at the same time. The other drugs that are being tested with the Study Drug are omeprazole, midazolam, flurbiprofen and simvastatin.
  Midazolam is a rapid-acting benzodiazepine used as a sedating agent, and is primarily metabolised (broken down) by CYP3A (A liver enzyme.)
  Simvastatin is primarily used to treat high cholesterol. The parent drug is readily metabolised by CYP3A in the liver.
  Omeprazole is a drug used to reduce gastric (stomach) acid secretion. Omeprazole is primarily metabolised by CYP2C19 in the liver.
  Flurbiprofen is a non-steroidal anti inflammatory drug and is primarily metabolised by CYP2C9 in the liver.
  The above mentioned medicines are considered and used experimentally as probe drug of respective enzymes.
  If PRB 01022 has any significant impact on CYP2C19, CYP3A4 or CYP2C9 enzymes, then this will affect the amount of corresponding probe drug in the blood stream and it can be assumed, that the same effect will occur with other medications that are regulated or broken down by the affected enzyme.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  14/LO/1343

• Date of REC Opinion

  8 Aug 2014

• REC opinion

  Favourable Opinion