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

Sponsored by:	Orion Corporation, Orion Pharma
Information provided by:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT00693316

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: ORM-12741	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title:	Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Single Ascending Doses of ORM-12741

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:

Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values [ Time Frame: About 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: 5 days after each dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	July 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ORM-12741: Experimental	Drug: ORM-12741 Alternating panel single dose escalation.
Placebo: Placebo Comparator	Drug: ORM-12741 Alternating panel single dose escalation.

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693316

Locations

Sponsors and Collaborators

Orion Corporation, Orion Pharma

Investigators

Study Director:

Jutta Hänninen, M.Sc.

Orion Corporation, Orion Pharma

More Information

Responsible Party:	Orion corporation, Orion Pharma ( Jutta Hänninen, Clinical study manager )
Study ID Numbers:	3098001
Study First Received:	May 30, 2008
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00693316
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Orion Corporation, Orion Pharma:

Healthy volunteer study

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009