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

NCT03240445 | Completed Phase 1

• 1 other identifier: 3113004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Area under the plasma concentration curve(AUC) ORM-21444 in the presence and absence of food

  0 to 72 hours

Study Arms (3)

Period 1

EXPERIMENTAL

ODM-203 dosed after food

Drug: ODM-203 (Period 1)

Period 2

EXPERIMENTAL

ODM-203 dosed before food

Drug: ODM-203 (Period 2)

Periods 3-6

EXPERIMENTAL

ODM-203 dosed as a tablet or dispersion

Drug: ODM-203 (Periods 3-6)

Interventions

ODM-203 (Period 1) DRUG

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

Period 1

ODM-203 (Period 2) DRUG

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

Period 2

ODM-203 (Periods 3-6) DRUG

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

Periods 3-6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Healthy male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead
• Quotient Clinical: collaborator

Study Sites (1)

Quotient Clinical Ltd

Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Clare Preskey, BSc

  Quotient Clinical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 7, 2017
• Study Start: August 24, 2017
• Primary Completion: October 23, 2017
• Study Completion: October 23, 2017
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

GB (1)