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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ORM-12741

• Registration Number: NCT00792493
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-18
• Study Start: 2008-12
• Primary Completion: 2009-06
• Status Verified: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2009-09-23
• Last Update Posted: 2009-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORM-12741	ORM-12741	-
Placebo	ORM-12741	-

Primary Outcome Measures

Name	Time	Method
Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values	about a month

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	12 days per period

Trial Locations

Locations (1)

Forenap Pharma; 🇫🇷 Rouffach, France