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

Study Overview
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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.

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

Official Title
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A Two-Part Open-Label, Single-Centre Mass Balance, Pharmacokinetics, Biotransformation and Absolute Bioavailability Study of ODM-201 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: ODM-201 300 mg tablet
* Drug: intravenous14C-ODM-201
* Drug: 300 mg 14C-ODM-201 oral solution


Participation Criteria
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Eligibility Criteria
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Key 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 Key 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>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 | Drug: ODM-201 300 mg tablet<br> <br> Drug: intravenous14C-ODM-201<br> <br> |
| Experimental: Part 2<br>A single oral solution of 300 mg 14C-ODM-201 containing no more than 6.3 MBq (171 microCi) 14C | Drug: 300 mg 14C-ODM-201 oral solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of 14C-ODM-201 dose excreted and cumulative amount excreted in urine and faeces and total. Amount excreted and cumulative amount excreted in urine, faeces and total expressed as a percentage of the administered dose. |  | Urine and faecal samples are collected baseline (Day-1) 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volunteers