Safety and Pharmacokinetic Study With Multiple Ascending Doses of ORM-12741

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-07-31

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of ORM-12741.

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Detailed Description

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The purpose is to evaluate the safety, tolerability and pharmacokinetics of escalating multiple doses of ORM-12741 in healthy volunteers.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo for ORM-12741

Group Type PLACEBO_COMPARATOR

Placebo for ORM-12741

Intervention Type DRUG

ORM-12741

Group Type EXPERIMENTAL

ORM-12741

Intervention Type DRUG

Ascending multiple doses to sequential panels

Interventions

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ORM-12741

Ascending multiple doses to sequential panels

Intervention Type DRUG

Placebo for ORM-12741

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, 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 medication during the study.
* Susceptibility to severe allergic reactions.
* Regular consumption of more than 14 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 3 months prior to the screening visit.
* Abnormal finding in ECG, vital signs, laboratory tests or physical examination.
* Intake of an investigational compound within 3 months prior to the start 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