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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo for ORM-12741; Drug: 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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rouffach, France
    • Forenap Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo for ORM-12741	Drug: Placebo for ORM-12741
EXPERIMENTAL: ORM-12741	Drug: ORM-12741; Ascending multiple doses to sequential panels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values	12 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: February 10, 2010
• First Submitted That Met QC Criteria: February 11, 2010
• First Posted (ESTIMATE): February 12, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 16, 2010
• Last Update Submitted That Met QC Criteria: August 13, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Healthy volunteer study
• Other Study ID Numbers: 3098008