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

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ODM-203 (Period 2); Drug: ODM-203 (Period 1); Drug: ODM-203 (Periods 3-6)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03240445

3113004

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Period 1

Experimental group

Description:

ODM-203 dosed after food

Treatment:

Drug: ODM-203 (Period 1)

Period 2

Experimental group

Description:

ODM-203 dosed before food

Treatment:

Drug: ODM-203 (Period 2)

Periods 3-6

Experimental group

Description:

ODM-203 dosed as a tablet or dispersion

Treatment:

Drug: ODM-203 (Periods 3-6)