NCT00792493

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Dec 2008

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 24, 2009

Status Verified

September 1, 2009

Enrollment Period

6 months

First QC Date

November 17, 2008

Last Update Submit

September 23, 2009

Conditions

Healthy

Keywords

Healthy volunteer study

Outcome Measures

Primary Outcomes (1)

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

    about a month

Secondary Outcomes (1)

  • Pharmacokinetics

    12 days per period

Study Arms (2)

ORM-12741

EXPERIMENTAL
Drug: ORM-12741

Placebo

PLACEBO COMPARATOR
Drug: ORM-12741

Interventions

ORM-12741DRUG

Alternating panel multiple dose escalation

ORM-12741Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forenap Pharma

Rouffach, France

Location

MeSH Terms

Interventions

ORM-12741

Study Officials

  • Déborah Metzger, Medical Doctor

    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

November 17, 2008

First Posted

November 18, 2008

Study Start

December 1, 2008

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

September 24, 2009

Record last verified: 2009-09

Locations

FR(1)