Phase I PK study of ODM-203 in healthy males (QCL118071)
Research type
Research Study
Full title
A Part-Randomised, Single Centre, Single Dose, Crossover, Phase I Study to Investigate the Impact of Changes to the Dosing Regimen on the Pharmacokinetic Profile of ODM-203 in Healthy Male Volunteers
IRAS ID
230929
Contact name
Nadja Heimonen
Contact email
Sponsor organisation
Orion Corporation, Orion Pharma
Eudract number
2017-001925-41
Duration of Study in the UK
0 years, 3 months, 12 days
Research summary
The Sponsor is developing the study drug, ODM-203, for the potential treatment of cancer. It is hoped that ODM-203 could be used to stop the growth of cancerous tumours.
The main aim of the study is to investigate the impact of different dosing conditions and formulations (recipes) on the level of ODM-203 in the blood.
The study will consist of 2 parts (Part 1 and optional Part 2). Sixteen healthy male subjects will be enrolled into Part 1 which is split into 6 study periods. A further 16 healthy male subjects may be enrolled into optional Part 2. In the first 2 study periods of Part 1 each subject will take 2 x ODM-203 200 mg tablets after breakfast (regimen A) and will take 2 x ODM-203 200 mg tablets 1 hour before breakfast (regimen B). Subjects will be randomised to receive treatment regimen A then B or B then A. The study medicine and conditions in subsequent treatment periods in both Part 1 and Part 2 will be determined based on review of emerging data. The study drug may be given in the fasted state or after an alternative meal composition to regimen A or after the meal is given at a different time to regimen A. The study drug could also be given after alternative fluid restrictions. The formulation of the study drug could also be altered to a different tablet form or as a powder mixed with water to drink. The study drug could be given with bile salts and/or lecithin.
On each dosing occasion subjects will stay in the clinical unit until 48h post-dose, returning to provide a blood sample at 72h post-dose. There will be at least 14 days between each study drug administration and subjects will return for follow-up 14 - 21 days after their final dose.
REC name
Wales REC 2
REC reference
17/WA/0248
Date of REC Opinion
11 Aug 2017
REC opinion
Favourable Opinion