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

O

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)

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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