Early Phase I Microdosing Study of ORM-14540 and ORM-12741

October 7, 2009 updated by: Orion Corporation, Orion Pharma

Pharmacokinetic Properties of ORM-14540 and ORM-12741 After Administration of a Microdose of 14C-labelled Drug; An Open, Non-randomised, Single Dose, Single Centre Study in Healthy Male Subjects

The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 and ORM-14540 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.

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.
6

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.
  • Early 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

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

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Written informed consent (IC) obtained.
  • Good general health ascertained by detailed medical history and physical examinations.
  • Males between 18 and 45 years (inclusive).
  • Body Mass Index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2).
  • Weight 55-100 kg (inclusive).

Exclusion Criteria:

  • A predictable poor compliance or inability to communicate well with the investigator or study centre personnel.
  • Veins unsuitable for repeated venipuncture
  • Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases as judged by the investigator.
  • Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant treatment during the study.
  • Susceptibility to severe allergic reactions.
  • Intake of any medication that could affect the outcome of the study, within 2 weeks prior to the first study treatment or less than 5 times a half-life of the medication. Possible enzyme inducing drugs will be discussed case-by-case with the sponsor.
  • Regular consumption of more than 21 units of alcohol per week (1 unit = 4 cl spirits, about 13 g of alcohol).
  • Current use of nicotine-containing products more than 5 cigarettes or equivalent/day.
  • Inability to refrain from using nicotine-containing products during the stay at the study centre.
  • Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre, e.g. propensity in getting headache when refraining from caffeine-containing beverages.
  • Blood donation or loss of significant amount of blood within 2 months prior to the screening visit.
  • Abnormal 12-lead electrocardiogram (ECG) finding of clinical relevance in supine position after resting for 10 minutes at the screening visit, for example:- QTc (calculated through the Bazett's formula) > 450msec,- PR < 120 msec or > 210 msec,- QRS < 70 msec or > 120 msec.
  • Heart rate (HR) < 45 beats/minute or > 100 beats/minute in supine position after resting for 10 minutes at the screening visit.
  • At the screening visit, systolic blood pressure (BP) < 90 mmHg or > 140 mmHg in supine position after resting for 10 minutes, diastolic BP < 50 mmHg or > 90 mmHg in supine position after resting for 10 minutes.
  • Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part into the study.
  • History of drug abuse or positive result in drug abuse test.
  • Positive serology to human immunodeficiency virus antigen/antibodies (HIVAgAb), hepatitis C virus antibodies (HCVAb) or hepatitis B surface antigen (HBsAg).
  • Any other condition that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health risk for the subject.
  • Participation in a clinical drug study within 3 months prior to the screening visit in this study, or earlier participation in a clinical study with ORM-12741.
  • Exposure to 14C-labelled drugs or diagnostics within 12 months prior to the screening visit.
  • Men who are not practising clinically accepted method of contraception during the study and next 3 months after the study treatment administration.

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: SINGLE_GROUP
  • 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.
ACTIVE_COMPARATOR: 14C-ORM-14540
Drug: ORM-14540
i.v.
ACTIVE_COMPARATOR: 14C-ORM-12741
Drug: ORM-12741
i.v.

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
Pharmacokinetic variables including: Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) at the end of infusion, Terminal elimination half-life (t½z), Total clearance (CL)
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Safety variables including blood pressure (BP), heart rate (HR), electrocardiograms (ECGs), physical examination, laboratory safety variables (haematology, chemistry, serology and urinalysis) and adverse events (AEs).
Time Frame: Before and after study
Before and after study

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

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.
January 1, 2009

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.
April 1, 2009

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.
April 1, 2009

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).
January 27, 2009

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.
January 27, 2009

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.
January 28, 2009

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.
October 8, 2009

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.
October 7, 2009

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.
October 1, 2009

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.
  • 3101001

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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