Pharmacokinetic Study of ORM-12741 in Healthy Volunteers

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: ORM-12741	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (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
Study Start Date :	January 2009
Actual Primary Completion Date :	June 2009
Actual Study Completion Date :	June 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes 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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Mononen/Clinical Study Manager, R&D
ClinicalTrials.gov Identifier:	NCT00818740 History of Changes
Other Study ID Numbers:	3098003
First Posted:	January 8, 2009
Last Update Posted:	October 8, 2009
Last Verified:	October 2009