Pharmacokinetic Study of ORM-12741 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00818740
First received: December 22, 2008
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Drug: ORM-12741
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of ORM-12741 After Intravenous and Oral Administration and Effects of Food on ORM-12741 Pharmacokinetics; An Open, Randomised, Single Dose, Single Centre, Crossover Study in Healthy Male Subjects

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

Primary Outcome Measures:
  • Pharmacokinetic variables including: Peak concentration in plasma (Cmax), Time to peak concentration in plasma (tmax), Area under the plasma concentration-time curve (AUC) [ Time Frame: 96 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: throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ORM-12741 i.v. Drug: ORM-12741
i.v., oral solution and oral capsule forms. Oral capsule given with and without food.
Experimental: ORM-12741 oral solution Drug: ORM-12741
i.v., oral solution and oral capsule forms. Oral capsule given with and without food.
Experimental: ORM-12741 oral capsule with food Drug: ORM-12741
i.v., oral solution and oral capsule forms. Oral capsule given with and without food.
Experimental: ORM-12741 oral capsule without food Drug: ORM-12741
i.v., oral solution and oral capsule forms. Oral capsule given with and without food.

  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.
  • Finnish speaking males between 18 and 45 years of age (inclusive).
  • Body Mass Index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2).
  • Weight of 55-100 kg (inclusive).

Exclusion criteria:

  • A predictable poor compliance or inability to communicate well with the investigator.
  • Veins unsuitable for repeated venipuncture.
  • Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease 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 administration or less than 5 times a half-live 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 at 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 ECG finding of clinical relevance after 10-minute rest in supine position 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.
  • HR < 45 beats/minute or > 100 beats/minute after 10-minute rest in supine position at the screening visit.
  • At the screening visit systolic blood pressure (BP) < 90 mmHg or > 140 mmHg after 10 minutes in supine position, diastolic BP < 50 mmHg or > 90 mmHg after 10 minutes in supine position.
  • Any abnormal value of laboratory, vital signs, 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 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 study subject.
  • Participation in a clinical drug study within 3 months prior to the first study treatment administration of this study or earlier participation in a clinical study with ORM-12741.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818740

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, R&D
ClinicalTrials.gov Identifier: NCT00818740     History of Changes
Other Study ID Numbers: 3098003
Study First Received: December 22, 2008
Last Updated: October 7, 2009
Health Authority: Finland: Finnish Medicines Agency

ClinicalTrials.gov processed this record on April 17, 2014