Comparative bioavailability of PYM50028 (Cogane™) in HVs (QBR113853)

• Research type

  Research Study

• Full title

  An Open label, Single Dose and Repeat Dose Bioavailability Study of PYM50028 (Cogane™) Formulations in Healthy Volunteers

• IRAS ID

  111911

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Phytopharm Plc

• Eudract number

  2012-003238-18

• Research summary

  The Sponsor is developing the study drug, PYM50028 (Cogane?½), for the potential treatment of Parkinson's disease and Amyotrophic Lateral Sclerosis (ALS), which are degenerative motor neuron diseases. The study will try to identify the pharmacokinetics, safety and tolerability of single and repeat doses of the study drug, when administered as two novel solid oral dose formulations (capsules). An oral solution will provide reference data. The study will dose PYM50028 to healthy subjects over 2 study parts. In Part 1, there will be up to four regimens as follows: Regimen A - 180 mg PYM50028 as MCT formulation (oral solution) Regimen B - 180 mg PYM50028 as PEG 6000 formulation (2 x 90 mg oral capsule) Regimen C - TBC mg PYM50028 MCT/Tween/Aerosil formulation (TBC x 90 mg oral capsule) Regimen D - TBC mg PYM50028 as either PEG 6000 or MCT/Tween/Aerosil formulation (TBC x 90 mg oral capsule) Some of the treatment regimens are optional. Dosing of Regimen C will only take place after combined review of interim PK and safety data folowing dosing with Regimen B, and Regimen D will only go ahead after similar interim analysis of dosing with Regimens B and/or C. Reference data from Regimen A will be used as necessary for these interim review steps. In Part 2, there will be one regimen as follows: Regimen E - TBC mg PYM50028 as PEG 6000 or MCT/Tween/Aerosil formulation (TBC x 90 mg oral capsule) administered daily for 28 days. The decision to proceed to Part 2, and the selection of dose level and dose frequency, will be based on review of PK and safety data from Part 1. The decision not to proceed may be taken if the data suggests that the test formulations do not have sufficient potential to attain the target PK profile.

• REC name

  HSC REC B

• REC reference

  12/NI/0126

• Date of REC Opinion

  6 Sep 2012

• REC opinion

  Further Information Favourable Opinion