Status:
COMPLETED
Impact of Changing the Dosing Regimen on the PK Profile of ODM-203
Lead Sponsor:
Orion Corporation, Orion Pharma
Collaborating Sponsors:
Quotient Clinical
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 da...
Eligibility Criteria
Inclusion
- 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
- 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
- Any abnormal laboratory value, vital signs, ECG parameter or physical examination interfering with the test results or causing a health risk for the subject or failure to satisfy the investigator of fitness to participate for any other reason.
Key Trial Info
Start Date :
August 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03240445
Start Date
August 24 2017
End Date
October 23 2017
Last Update
May 14 2019
Active Locations (1)
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1
Quotient Clinical Ltd
Nottingham, United Kingdom, NG11 6JS