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

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ODM-201 300 mg tablet; Drug: intravenous14C-ODM-201; Drug: 300 mg 14C-ODM-201 oral solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02418650

3104005

Details and patient eligibility

About

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.

Full description

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

Enrollment: 12 patients

Sex: Male

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Part 1

Experimental group

Description:

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

Treatment:

Drug: intravenous14C-ODM-201

Drug: ODM-201 300 mg tablet

Part 2

Experimental group

Description:

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

Treatment:

Drug: 300 mg 14C-ODM-201 oral solution