Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of ORM-12741

Orion Corporation, Orion Pharma1 site in 1 country49 target enrollmentFebruary 2010

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: ORM-12741
Conditions: Healthy
Sponsor: Orion Corporation, Orion Pharma
Enrollment: 49
Locations: 1
Primary Endpoint: Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values
Status: Completed
Last Updated: 15 years ago

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

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

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

July 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Sponsor

•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).

•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