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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ORM-12741

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rouffach, France, 68250
    • 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
• 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 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	Drug: ORM-12741; Alternating panel single dose escalation.
EXPERIMENTAL: ORM-12741	Drug: ORM-12741; Alternating panel single dose escalation.

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	About 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics	5 days after each dose

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): October 1, 2009
• Study Completion (ACTUAL): October 1, 2009

Study Registration Dates

• First Submitted: May 30, 2008
• First Submitted That Met QC Criteria: June 6, 2008
• First Posted (ESTIMATE): June 9, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): February 11, 2010
• Last Update Submitted That Met QC Criteria: February 10, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Healthy volunteer study
• Other Study ID Numbers: 3098001