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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Orion Corporation, Orion Pharma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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