Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Multiple Ascending Doses of ORM-12741

Orion Corporation, Orion Pharma1 site in 1 country51 target enrollmentDecember 2008

ConditionsHealthy

InterventionsORM-12741

Overview

Phase: Phase 1
Intervention: ORM-12741
Conditions: Healthy
Sponsor: Orion Corporation, Orion Pharma
Enrollment: 51
Locations: 1
Primary Endpoint: Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values
Status: Completed
Last Updated: 16 years ago

The purpose of this study is to evaluate the safety and tolerability of escalating multiple doses of ORM-12741 in healthy volunteers

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

September 2009

Last Updated

16 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
•Body mass index (BMI) between 18-30 kg/m2
•Weight 55-90 kg

•Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease
•Any condition requiring regular concomitant treatment including herbal products or likely to need any concomitant treatment during the study
•Susceptibility to severe allergic reactions
•Regular consumption of more than 14 units of alcohol per week
•Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
•Inability to refrain from using nicotine-containing products during the stay in the study centre
•Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre
•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
•Participation in a drug study within 3 months prior to the start of this study