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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-24

Study Completion Date

2017-10-23

Brief Summary

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

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Period 1

ODM-203 dosed after food

Group Type EXPERIMENTAL

ODM-203 (Period 1)

Intervention Type DRUG

ODM-203 400mg as tablets taken 30 minutes after food

Period 2

ODM-203 dosed before food

Group Type EXPERIMENTAL

ODM-203 (Period 2)

Intervention Type DRUG

ODM-203 400mg as tablets taken 1 hour before a light breakfast

Periods 3-6

ODM-203 dosed as a tablet or dispersion

Group Type EXPERIMENTAL

ODM-203 (Periods 3-6)

Intervention Type DRUG

ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food

Interventions

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ODM-203 (Period 1)

ODM-203 400mg as tablets taken 30 minutes after food

Intervention Type DRUG

ODM-203 (Period 2)

ODM-203 400mg as tablets taken 1 hour before a light breakfast

Intervention Type DRUG

ODM-203 (Periods 3-6)

ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes