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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01068028
• Date of registration: 10/02/2010
• Prospective Registration: No
• Primary sponsor: Orion Corporation, Orion Pharma
• Public title: Safety and Pharmacokinetic Study With Multiple Ascending Doses of ORM-12741
• Scientific title: Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of ORM-12741
• Date of first enrolment: February 2010
• Target sample size: 49
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01068028
• 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, MD
• 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 (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



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

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Placebo for ORM-12741

Drug: ORM-12741

Primary Outcome(s)

Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values [Time Frame: 12 days]

Secondary Outcome(s)

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

Secondary ID(s)

3098008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors