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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00693316

Enrollment

120

Registered

2008-06-09

Start date

2008-07-31

Completion date

2009-10-31

Last updated

2010-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volunteer study

Brief summary

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

Interventions

DRUGORM-12741

Alternating panel single dose escalation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values	About 8 weeks

Secondary

Measure	Time frame
Pharmacokinetics	5 days after each dose

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026