Pharmacokinetic Study of ORM-12741 in Healthy Volunteers

NCT ID: NCT00818740

Last Updated: 2009-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-06-30

Brief Summary

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

ORM-12741 i.v.

Group Type: EXPERIMENTAL

ORM-12741

Intervention Type: DRUG

i.v., oral solution and oral capsule forms. Oral capsule given with and without food.

ORM-12741 oral solution

Group Type: EXPERIMENTAL

ORM-12741

Intervention Type: DRUG

i.v., oral solution and oral capsule forms. Oral capsule given with and without food.

ORM-12741 oral capsule with food

Group Type: EXPERIMENTAL

ORM-12741

Intervention Type: DRUG

i.v., oral solution and oral capsule forms. Oral capsule given with and without food.

ORM-12741 oral capsule without food

Group Type: EXPERIMENTAL

ORM-12741

Intervention Type: DRUG

i.v., oral solution and oral capsule forms. Oral capsule given with and without food.

Interventions

ORM-12741

i.v., oral solution and oral capsule forms. Oral capsule given with and without food.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

R&D

Principal Investigators

Juha Peltonen, MD

Role: PRINCIPAL_INVESTIGATOR

CRST

Virpi Mononen

Role: STUDY_DIRECTOR

Orion Corporation, Orion Pharma

Locations

CRST

Turku, , Finland

Countries

Finland

Other Identifiers

3098003

Identifier Type: -

Identifier Source: org_study_id