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
Overview
- Phase
- Phase 1
- Intervention
- ODM-203 (Period 1)
- Conditions
- Healthy
- Sponsor
- Orion Corporation, Orion Pharma
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent
- •Able to speak, write and understand English
- •Body mass index of 18.0-32.0
- •Weight 55-95 kg
- •Adequate method of contraception
- •Good state of health
Exclusion Criteria
- •Receipt of IMP in a clinical research study or donation/loss of \>400ml blood within previous 3 months or previously enrolled in this study
- •History of drug or alcohol abuse or positive drugs of abuse test or regular alcohol consumption or current smoker/user of nicotine replacement products
- •Positive drugs of abuse test
- •Positive hepatitis B, hepatitis C or HIV results
- •Donation/loss of \>400ml blood within previous 3 months
- •Poor compliance or inability to follow protocol requirements/instructions/restrictions.
- •Vulnerable subjects
- •Evidence of clinically relevant disease of any body system including relevant psychiatric disorders or conditions requiring regular concomitant medication
- •History of significant hypersensitivity, anaphylaxis, intolerance to drugs/food
- •Propensity to get headaches when refraining from caffeine containing beverages
Arms & Interventions
Period 1
ODM-203 dosed after food
Intervention: ODM-203 (Period 1)
Period 2
ODM-203 dosed before food
Intervention: ODM-203 (Period 2)
Periods 3-6
ODM-203 dosed as a tablet or dispersion
Intervention: ODM-203 (Periods 3-6)
Outcomes
Primary Outcomes
Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food
Time Frame: 0 to 72 hours
Area under the plasma concentration curve (AUC) will be measured to investigate the pharmacokinetic profile of ODM-203 in the presence and absence of food
Secondary Outcomes
- Number of adverse events(From the date of informed consent to the date of the end of study estimated to be up to 17 weeks)
- Area under the plasma concentration curve(AUC) ORM-21444 in the presence and absence of food(0 to 72 hours)