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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ODM-201 300 mg tablet; Drug: 300 mg 14C-ODM-201 oral solution; Drug: intravenous14C-ODM-201

• Registration Number: NCT02418650
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

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

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

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-16
• Primary Completion: 2015-05
• Status Verified: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1	ODM-201 300 mg tablet	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
Part 1	intravenous14C-ODM-201	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
Part 2	300 mg 14C-ODM-201 oral solution	A single oral solution of 300 mg 14C-ODM-201 containing no more than 6.3 MBq (171 microCi) 14C

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Nottingham, United Kingdom