Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-06-30

Brief Summary

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A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance and routes of excretion of ODM-201 in healthy volunteers.

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Detailed Description

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6 healthy male subjects will be enrolled in part 1 and part 2 of the study, respectively

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part 1

A single oral 300 mg tablet of ODM-201 followed by single intravenous 100 microg of 14C-ODM-201 containing not more than 37 kBq (1000 nCi)14C

Group Type EXPERIMENTAL

ODM-201 300 mg tablet

Intervention Type DRUG

intravenous14C-ODM-201

Intervention Type DRUG

Part 2

A single oral solution of 300 mg 14C-ODM-201 containing no more than 6.3 MBq (171 microCi) 14C

Group Type EXPERIMENTAL

300 mg 14C-ODM-201 oral solution

Intervention Type DRUG

Interventions

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ODM-201 300 mg tablet

Intervention Type DRUG

intravenous14C-ODM-201

Intervention Type DRUG

300 mg 14C-ODM-201 oral solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males
* Aged 50 to 65 years (inclusive)
* Normal weight defined as a body mass index (BMI) of \>18.5 and \<32.0 kg/m2
* Weight 55 to 100 kg (inclusive)
* Adequate method of contraception during the study and for a period of 6 months after study drug administration

Exclusion Criteria

* Evidence of clinically significant disease
* Intake of any medication that could affect the outcome of the study
* Known hypersensitivity to the active substances or the excipients of the drug or any serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
* History of anaphylactic/anaphylactoid reactions
* Clinically significant abnormal biochemistry, haematology or urinalysis
* Current or history of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
* Current use or use within the last 12 months of nicotine products
* Positive drugs of abuse test result
* Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results
* Presence or history of clinically significant allergy requiring treatment

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes