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

NCT03240445 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-05-14

No results posted yet for this study

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

Interventions

DRUG

ODM-203 (Period 1)

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

DRUG

ODM-203 (Period 2)

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

DRUG

ODM-203 (Periods 3-6)

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

Sponsors & Collaborators

  • Quotient Clinical

    collaborator OTHER

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Clare Preskey, BSc · Quotient Clinical

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-24
Primary Completion
2017-10-23
Completion
2017-10-23

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03240445 on ClinicalTrials.gov