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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ODM-203 (Period 1); Drug: ODM-203 (Period 2); Drug: ODM-203 (Periods 3-6)

• Registration Number: NCT03240445
• Lead Sponsor: Orion Corporation, Orion Pharma

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.

Study Timeline

• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-07
• Study Start: 2017-08-24
• Primary Completion: 2017-10-23
• Study Completion: 2017-10-23
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 1	ODM-203 (Period 1)	ODM-203 dosed after food
Period 2	ODM-203 (Period 2)	ODM-203 dosed before food
Periods 3-6	ODM-203 (Periods 3-6)	ODM-203 dosed as a tablet or dispersion

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food	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 Outcome Measures

Name	Time	Method
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	Number of adverse events counts
Area under the plasma concentration curve(AUC) ORM-21444 in the presence and absence of food	0 to 72 hours	Area under the plasma concentration curve (AUC) will be measured to investigate the pharmacokinetic profile of ORM-21444 in the presence and absence of food

Trial Locations

Locations (1)

Quotient Clinical Ltd; 🇬🇧 Nottingham, United Kingdom