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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo for ORM-12741; Drug: ORM-12741

• Registration Number: NCT01068028
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-10
• Study First Submitted QC: 2010-02-11
• Study First Posted: 2010-02-12
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-13
• Last Update Posted: 2010-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values	12 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile (Cmax, tmax, t1/2, AUC, PTF) of ORM-12741 and its metabolites	PK samples will be collected for 12 days

Trial Locations

Locations (1)

Forenap Pharma; 🇫🇷 Rouffach, France