Safety and Tolerability Study With Single Ascending Doses of ORM-12741

Orion Pharma

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ORM-12741

Study type

Interventional

Funder types

Industry

Identifiers

3098001

Details and patient eligibility

About

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

Enrollment

120 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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