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

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00831077
First received: January 27, 2009
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Healthy
Drug: ORM-14540
Drug: ORM-12741
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 14C-ORM-14540 Drug: ORM-14540
i.v.
Active Comparator: 14C-ORM-12741 Drug: ORM-12741
i.v.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831077

Locations
Finland
CRST
Turku, Finland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Juha Peltonen, MD CRST
Study Director: Virpi Mononen Orion Corporation, Orion Pharma
  More Information

No publications provided

Responsible Party: Mononen/Clinical Study Manager, Development
ClinicalTrials.gov Identifier: NCT00831077     History of Changes
Other Study ID Numbers: 3101001
Study First Received: January 27, 2009
Last Updated: October 7, 2009
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Orion Corporation, Orion Pharma:
Healthy volunteers

ClinicalTrials.gov processed this record on April 23, 2014