Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2014-09-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Panel 1
Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these
ORM-12741 MR A
Modified release formulation of ORM-12741
ORM-12741 IR
Immediate release formulation of ORM-12741
ORM-12741 MR B
Modified release formulation of ORM-12741
Panel 2
Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these
ORM-12741 MR A
Modified release formulation of ORM-12741
ORM-12741 IR
Immediate release formulation of ORM-12741
ORM-12741 MR B
Modified release formulation of ORM-12741
Panel 3
Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these
ORM-12741 MR A
Modified release formulation of ORM-12741
ORM-12741 IR
Immediate release formulation of ORM-12741
ORM-12741 MR B
Modified release formulation of ORM-12741
Panel 4
Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these
ORM-12741 MR A
Modified release formulation of ORM-12741
ORM-12741 IR
Immediate release formulation of ORM-12741
ORM-12741 MR B
Modified release formulation of ORM-12741
Panel 5
Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these
ORM-12741 MR A
Modified release formulation of ORM-12741
ORM-12741 IR
Immediate release formulation of ORM-12741
ORM-12741 MR B
Modified release formulation of ORM-12741
Panel 6
Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these
ORM-12741 MR A
Modified release formulation of ORM-12741
ORM-12741 IR
Immediate release formulation of ORM-12741
ORM-12741 MR B
Modified release formulation of ORM-12741
Interventions
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ORM-12741 MR A
Modified release formulation of ORM-12741
ORM-12741 IR
Immediate release formulation of ORM-12741
ORM-12741 MR B
Modified release formulation of ORM-12741
Eligibility Criteria
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Inclusion Criteria
2. Good general health ascertained by detailed medical history and physical examination.
3. Females and males between 18 and 65 years of age (inclusive).
4. Body mass index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2).
5. Weight of 50-100 kg (inclusive).
6. Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems).
Exclusion Criteria
2. Veins unsuitable for repeated venipuncture or cannulation.
3. Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator.
4. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. Hormonal contraception and hormone replacement therapy are allowed.
5. Susceptibility to severe allergic reactions.
6. 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 the half-life of the medication. Possible enzyme inducing drugs will be discussed case-by-case with the sponsor.
7. Regular consumption of more than 21 units of alcohol per week for males and 16 units per week for females (1 unit = 4 cl spirits, about 13 g of alcohol).
8. Current use of nicotine-containing products more than 5 cigarettes or equivalent/day.
9. Inability to refrain from using nicotine-containing products during the stay at the study centre.
10. Inability to refrain from consuming caffeine-containing beverages during the stay at the study centre, e.g. propensity to develop headaches when refraining from caffeine-containing beverages.
11. Blood donation or loss of significant amount of blood within 3 months prior to the first study treatment administration.
12. Any clinically significant 12-lead electrocardiogram (ECG) abnormality after a 10-minute rest in supine position at the screening visit, as judged by the investigator. For example:
* QTc (calculated with the Bazett's formula) \> 470 msec for females and 450 msec for men.
13. HR \< 45 beats/minute or \> 100 beats/minute after a 10-minute rest in supine position at the screening visit.
14. At the screening visit systolic blood pressure (BP) \< 90 mmHg or \> 150 mmHg after a 10- minute rest in supine position, diastolic BP \< 50 mmHg or \> 90 mmHg after a 10-minute rest in supine position, or symptomatic orthostatic hypotension, or
* decrease of ≥ 20 mmHg of systolic BP or
* decrease of ≥ 10 mmHg of diastolic BP after 3 minutes in standing position.
15. Any abnormal value in laboratory tests, or vital signs, or physical examination finding, which in the opinion of the investigator could interfere with the interpretation of the test results or cause a health risk for the subject if he takes part in the study.
16. History of drug abuse or positive result in drug abuse test.
17. Positive serology to human immunodeficiency virus antibodies (HIVAgAb), hepatitis C virus antibodies (HCVAb) or hepatitis B surface antigen (HBsAg).
18. Females of childbearing potential if they are not using proper contraception (hormonal contraception, intrauterine device \[IUD\] or surgical sterilization, spermicidal foam in conjunction with condom on male partner) during the study. Use of oral/hormonal contraception alone is not acceptable. (Note: women of childbearing potential with no current heterosexual relationship can be included without contraception according to the judgement of the investigator).
19. 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.
20. 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Mika Scheinin, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Services Turku, CRST
Locations
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Clinical Research Services Turku, CRST
Turku, , Finland
Countries
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Other Identifiers
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2014-000193-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3098011
Identifier Type: -
Identifier Source: org_study_id
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