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

O

Orion Pharma

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo for ORM-12741
Drug: ORM-12741

Study type

Interventional

Funder types

Industry

Identifiers

NCT01068028
3098008

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of ORM-12741.

Full description

The purpose is to evaluate the safety, tolerability and pharmacokinetics of escalating multiple doses of ORM-12741 in healthy volunteers.

Enrollment

49 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

49 participants in 2 patient groups, including a placebo group

Placebo for ORM-12741
Placebo Comparator group
Treatment:
Drug: Placebo for ORM-12741
ORM-12741
Experimental group
Treatment:
Drug: ORM-12741

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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