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

Healthy Clinical Trial

— KIPEV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240445
• Other study ID #: 3113004
• Status: Completed
• Phase: Phase 1
• Start date: August 24, 2017
• Est. completion date: October 23, 2017

Study information

• Verified date: May 2019
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 23, 2017
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ODM-203 (Period 1)
ODM-203 400mg as tablets taken 30 minutes after food
• ODM-203 (Period 2)
ODM-203 400mg as tablets taken 1 hour before a light breakfast
• ODM-203 (Periods 3-6)
ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical Ltd	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma	Quotient Clinical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food	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	0 to 72 hours
Secondary	Number of adverse events	Number of adverse events counts	From the date of informed consent to the date of the end of study estimated to be up to 17 weeks
Secondary	Area under the plasma concentration curve(AUC) ORM-21444 in the presence and absence of food	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	0 to 72 hours