Clinical trial NCT03240445: Impact of Changing the Dosing Regimen on the PK Profile of ODM-203
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
Collaborators: name: Quotient Clinical
First posted: 2017-08-07
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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
* 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.

Primary outcomes:
measure: Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food
timeFrame: 0 to 72 hours
Secondary outcomes:
measure: Number of adverse events
timeFrame: From the date of informed consent to the date of the end of study estimated to be up to 17 weeks
measure: Area under the plasma concentration curve(AUC) ORM-21444 in the presence and absence of food
timeFrame: 0 to 72 hours
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical Ltd
Study officials:
affiliation: Quotient Clinical
name: Clare Preskey, BSc
role: STUDY_DIRECTOR
References: