NCT00693316

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of escalating 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
120

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2008

Longer than P75 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

May 30, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 9, 2008

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 11, 2010

Status Verified

February 1, 2010

Enrollment Period

1.3 years

First QC Date

May 30, 2008

Last Update Submit

February 10, 2010

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 8 weeks

Secondary Outcomes (1)

  • Pharmacokinetics

    5 days after each dose

Study Arms (2)

ORM-12741

EXPERIMENTAL
Drug: ORM-12741

Placebo

PLACEBO COMPARATOR
Drug: ORM-12741

Interventions

ORM-12741DRUG

Alternating panel single 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, 68250, 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

May 30, 2008

First Posted

June 9, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 11, 2010

Record last verified: 2010-02

Locations

FR(1)