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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00792493
• Date of registration: 17/11/2008
• Prospective Registration: Yes
• Primary sponsor: Orion Corporation, Orion Pharma
• Public title: Safety and Tolerability Study With Multiple Ascending Doses of ORM-12741
• Scientific title: Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Multiple Ascending Doses of ORM-12741
• Date of first enrolment: December 2008
• Target sample size: 51
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00792493
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Déborah Metzger, Medical Doctor
• Affiliation: Forenap Pharma

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: ORM-12741

Primary Outcome(s)

Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values [Time Frame: about a month]

Secondary Outcome(s)

Pharmacokinetics [Time Frame: 12 days per period]

Secondary ID(s)

3098002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors