NCT03240445

Impact of Changing the Dosing Regimen on the PK Profile of ODM-203

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This Phase I study in healthy male volunteers will evaluate the impact of the effect of food on the pharmacokinetic profile of ODM-203.

Detailed description

This study will be a single dose part randomised cross over study with up to 6 study periods. ODM-203 may be dosed using a variety of different conditions with respect to food depending on emerging data. The impact of changing the presentation of ODM-203 may also be assessed to determine the PK of alternative formulations and identify appropriate drug formulations for further development.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ODM-203 (Period 1)	ODM-203 400mg as tablets taken 30 minutes after food
DRUG	ODM-203 (Period 2)	ODM-203 400mg as tablets taken 1 hour before a light breakfast
DRUG	ODM-203 (Periods 3-6)	ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food

Timeline

• Start date: 2017-08-24
• Primary completion: 2017-10-23
• Completion: 2017-10-23
• First posted: 2017-08-07
• Last updated: 2019-05-14

Locations

1 site across 1 country: United Kingdom