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

NCT01068028 | Completed Phase 1 DMC

• 1 other identifier: 3098008
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy volunteer study

Outcome Measures

Primary Outcomes (1)

• Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values

  12 days

Secondary Outcomes (1)

• Pharmacokinetic profile (Cmax, tmax, t1/2, AUC, PTF) of ORM-12741 and its metabolites

  PK samples will be collected for 12 days

Study Arms (2)

Placebo for ORM-12741

PLACEBO COMPARATOR

Drug: Placebo for ORM-12741

ORM-12741

EXPERIMENTAL

Drug: ORM-12741

Interventions

ORM-12741 DRUG

Ascending multiple doses to sequential panels

ORM-12741

Placebo for ORM-12741 DRUG

Placebo for ORM-12741

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Forenap Pharma

Rouffach, France

Location

MeSH Terms

Interventions

ORM-12741

Study Officials

• Déborah Metzger, MD

  Forenap Pharma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 12, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

FR (1)