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

June 22, 2015 updated by: Orion Corporation, Orion Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG11 6JS
        • Quotient Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Drug: ODM-201 300 mg tablet
Drug: intravenous14C-ODM-201
EXPERIMENTAL: Part 2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 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
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolite profile of 14C-ODM-201 in plasma, urine and faeces
Time Frame: up to 14 days post-dose after oral solution dosing
up to 14 days post-dose after oral solution dosing
Maximum concentration (Cmax) of 14C-radioactivity in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing
Time to maximum concentration (tmax) of 14C-radioactivity in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing
Area under the plasma concentration-time curve (AUC(0-t)) of 14C-radioactivity in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing
Area under the plasma concentration-time curve (AUC(0-infinity)) of 14C-radioactivity in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing
Half life (t1/2) of 14C-radioactivity in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing
Maximum concentration (Cmax) of ODM-201 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
Time to maximum concentration (tmax) of ODM-201 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
Area under the plasma concentration-time curve (AUC(0-t)) of ODM-201 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
Area under the plasma concentration-time curve (AUC(0-infinity)) of ODM-201 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
Half life (t1/2) of ODM-201 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
Maximum concentration (Cmax) of metabolite ORM 15341 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
Time to maximum concentration (tmax) of metabolite ORM 15341 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
Area under the plasma concentration-time curve (AUC(0-t)) of metabolite ORM 15341 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
Area under the plasma concentration-time curve (AUC(0-infinity)) of metabolite ORM 15341 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
Half life (t1/2) of metabolite ORM 15341 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing
Maximum concentration (Cmax) of metabolite 14C-ORM 15341 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing
The samples were taken 72 h post-dose after IV dosing
Time to maximum concentration (tmax) of metabolite 14C-ORM 15341 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing
The samples were taken 72 h post-dose after IV dosing
Area under the plasma concentration-time curve (AUC(0-t)) of metabolite 14C-ORM 15341 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing
The samples were taken 72 h post-dose after IV dosing
Area under the plasma concentration-time curve (AUC(0-infinity)) of metabolite 14C-ORM 15341 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing
The samples were taken 72 h post-dose after IV dosing
Half life (t1/2) of metabolite 14C-ORM 15341 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing
The samples were taken 72 h post-dose after IV dosing
Maximum concentration (Cmax) of 14C-ODM-201 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing
The samples were taken 72 h post-dose after IV dosing
Time to maximum concentration (tmax) of 14C-ODM-201 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing
The samples were taken 72 h post-dose after IV dosing
Area under the plasma concentration-time curve (AUC(0-t)) of 14C-ODM-201 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing
The samples were taken 72 h post-dose after IV dosing
Area under the plasma concentration-time curve (AUC(0-infinity)) of 14C-ODM-201 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing
The samples were taken 72 h post-dose after IV dosing
Half life (t1/2) of 14C-ODM-201 in plasma
Time Frame: The samples were taken 72 h post-dose after IV dosing
The samples were taken 72 h post-dose after IV dosing
Maximum concentration (Cmax) of 14C-radioactivity in whole blood
Time Frame: The samples were taken 24 h post-dose after oral solution dosing
The samples were taken 24 h post-dose after oral solution dosing
Time to maximum concentration (tmax) of 14C-radioactivity in whole blood
Time Frame: The samples were taken 24 h post-dose after oral solution dosing
The samples were taken 24 h post-dose after oral solution dosing
Area under the plasma concentration-time curve (AUC(0-t)) of 14C-radioactivity in whole blood
Time Frame: The samples were taken 24 h post-dose after oral solution dosing
The samples were taken 24 h post-dose after oral solution dosing
Renal elimination for ODM-201 in urine
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 d post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 14 d post-dose after oral solution dosing
Renal elimination for 14C-ODM-201 in urine
Time Frame: The samples were taken up-to 14 d post-dose after oral solution dosing
The samples were taken up-to 14 d post-dose after oral solution dosing
Fraction absorbed (FA) of total radioactivity based on urinary recovery of total radioactivity for both IV and oral dosing
Time Frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 d post-dose after oral solution dosing
The samples were taken 72 h post-dose after IV dosing and up-to 14 d post-dose after oral solution dosing
Adverse events
Time Frame: Collected 7 days post-dose in part 1 and up to 14 days post-dose in part 2
Collected 7 days post-dose in part 1 and up to 14 days post-dose in part 2
Physical examination
Time Frame: Assessed at screening, pre-dose, at discharge from the study centre (72 h and 7 d post-dose in part 1 and latest at 14 d post-dose in part 2)
Full physical examination
Assessed at screening, pre-dose, at discharge from the study centre (72 h and 7 d post-dose in part 1 and latest at 14 d post-dose in part 2)
Blood pressure
Time Frame: Assessed at screening, pre-dose, 3 h, 5 h, 12 h, 24 h, 36 h and 48 h post-dose and at discharge from the study centre (72 h post-dose in part 1 and latest at 14 d post-dose in part 2) and in addition in part 1 7 d post-dose
Assessed at screening, pre-dose, 3 h, 5 h, 12 h, 24 h, 36 h and 48 h post-dose and at discharge from the study centre (72 h post-dose in part 1 and latest at 14 d post-dose in part 2) and in addition in part 1 7 d post-dose
Heart rate
Time Frame: Assessed at screening, pre-dose, 3 h, 5 h, 12 h, 24 h, 36 h and 48 h post-dose and at discharge from the study centre (72 h post-dose in part 1 and latest at 14 d post-dose in part 2) and in addition in part 1 7 d post-dose
Assessed at screening, pre-dose, 3 h, 5 h, 12 h, 24 h, 36 h and 48 h post-dose and at discharge from the study centre (72 h post-dose in part 1 and latest at 14 d post-dose in part 2) and in addition in part 1 7 d post-dose
Oral temperature
Time Frame: Assessed at screening, pre-dose, 3 h, 5 h, 12 h, 24 h, 36 h and 48 h post-dose and at discharge from the study centre (72 h post-dose in part 1 and latest at 14 d post-dose in part 2) and in addition in part 1 7 d post-dose
Assessed at screening, pre-dose, 3 h, 5 h, 12 h, 24 h, 36 h and 48 h post-dose and at discharge from the study centre (72 h post-dose in part 1 and latest at 14 d post-dose in part 2) and in addition in part 1 7 d post-dose
12-lead ECG
Time Frame: Assessed at screening, pre-dose, 3 h, 5 h, 12 h, 24 h, 36 h and 48 h post-dose and at discharge from the study centre (72 h post-dose in part 1 and latest at 14 d post-dose in part 2) and in addition in part 1 7 d post-dose
Assessed at screening, pre-dose, 3 h, 5 h, 12 h, 24 h, 36 h and 48 h post-dose and at discharge from the study centre (72 h post-dose in part 1 and latest at 14 d post-dose in part 2) and in addition in part 1 7 d post-dose
Clinical chemistry
Time Frame: Assessed at screening, pre-dose, 24 h and 48 h post-dose and 7 d post-dose in part 1 and latest at 14 d post-dose in part 2
Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin (Total), Calcium, Creatinine, Creatinine clearance, Lactate dehydrogenase, Potassium, Sodium and Urea
Assessed at screening, pre-dose, 24 h and 48 h post-dose and 7 d post-dose in part 1 and latest at 14 d post-dose in part 2
Haematology
Time Frame: Assessed at screening, pre-dose, 24 h and 48 h post-dose and 7 d post-dose in part 1 and latest at 14 d post-dose in part 2
Basophils, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes, MCH, MCHC, MCV, Monocytes, Neutrophils, Red Blood Cell Count, White Blood Cell Count and Thrombocytes
Assessed at screening, pre-dose, 24 h and 48 h post-dose and 7 d post-dose in part 1 and latest at 14 d post-dose in part 2
Urinalysis
Time Frame: Assessed at screening, pre-dose, 24 h and 48 h post-dose and 7 d post-dose in part 1 and latest at 14 d post-dose in part 2
Leucocytes, protein, erythrocytes, glucose and specific gravity
Assessed at screening, pre-dose, 24 h and 48 h post-dose and 7 d post-dose in part 1 and latest at 14 d post-dose in part 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Collaborators

Bayer

Investigators

  • Principal Investigator: Philip Evans, MB ChB MRCS, Quotient Clinical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (ESTIMATE)

April 16, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3104005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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