A study to investigate the PK profile of palmitoylethanolamide (PEA)

  • Research type

    Research Study

  • Full title

    A STUDY TO EVALUATE THE PHARMACOKINETICS OF PALMITOYLETHANOLAMIDE IN HEALTHY VOLUNTEERS

  • IRAS ID

    252210

  • Contact name

    Samuel Israel

  • Contact email

    samuel.israel@covance.com

  • Sponsor organisation

    Carnot Pharma LLC

  • Duration of Study in the UK

    0 years, 1 months, 19 days

  • Research summary

    This study is a 3-treatment period, single-dose study investigating the pharmacokinetic profile of a marketed food supplement known as Normast in both fed and fasted states.

    Normast is a food supplement which has been marketed in Europe for over 10 years. Normast contains a chemical known as palmitoylethanolamide (known as PEA for short). This chemical is a fatty acid which is found naturally within the body and has properties which have been associated with reducing pain and inflammation. In conditions where pain and inflammation are a symptom, there are generally low levels of PEA in the body and therefore the body’s natural responses to pain and inflammation could be slowed. Therefore, by taking a supplement which contains PEA, the levels in the body could be boosted which could help in reducing the levels of pain and inflammation.

    This study will be conducted in 8 healthy males and females aged between 18 and 55 years of age.

    There will be 3 treatment periods: TP1 involves the administration of one 300 mg dose of Normast in the fasted state, TP2 involves the administration of one 300 mg dose of Normast in the fed state (following a high fat breakfast) and TP3 involves the administration of one 600 mg dose of Normast in either the fed or fasted state (this will be determined following review of TP1 and TP2 PK data).

    The purpose of the study is to determine the PK profile of Normast. This profile will then be used to support the development work of a new product being developed by the study sponsor Carnot, LLC.

  • REC name

    Wales REC 1

  • REC reference

    18/WA/0288

  • Date of REC Opinion

    6 Sep 2018

  • REC opinion

    Favourable Opinion