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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014