Clinical trial NCT00831077: Early Phase I Microdosing Study of ORM-14540 and ORM-12741
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2009-01-28
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: 72 hours
Secondary outcomes:
measure: 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).
timeFrame: Before and after study
Other outcomes:
Locations:
city: Turku
country: Finland
facility: CRST
Study officials:
affiliation: CRST
name: Juha Peltonen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orion Corporation, Orion Pharma
name: Virpi Mononen
role: STUDY_DIRECTOR
References: