Status:
COMPLETED
Early Phase I Microdosing Study of ORM-14540 and ORM-12741
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 and ORM-14540 in healthy volunteers.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00831077
Start Date
January 1 2009
End Date
April 1 2009
Last Update
October 8 2009
Active Locations (1)
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1
CRST
Turku, Finland