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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ODM-203 (Period 1); Drug: ODM-203 (Period 2); Drug: ODM-203 (Periods 3-6)

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Quotient Clinical Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Period 1; ODM-203 dosed after food	Drug: ODM-203 (Period 1); ODM-203 400mg as tablets taken 30 minutes after food
EXPERIMENTAL: Period 2; ODM-203 dosed before food	Drug: ODM-203 (Period 2); ODM-203 400mg as tablets taken 1 hour before a light breakfast
EXPERIMENTAL: Periods 3-6; ODM-203 dosed as a tablet or dispersion	Drug: ODM-203 (Periods 3-6); ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma
• Collaborators: Quotient Clinical
• Investigators: Study Director: Clare Preskey, BSc, Quotient Clinical

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 24, 2017
• Primary Completion (ACTUAL): October 23, 2017
• Study Completion (ACTUAL): October 23, 2017

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (ACTUAL): August 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 3113004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No