NCT00977886

Brief Summary

The purpose of this trial is to study the safety and tolerability of repeated oral doses of ELB353, to evaluate the plasma levels of ELB353 and to study their effect on substances mediating inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2009

Typical duration for phase_1 healthy-volunteers

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

Study Start

First participant enrolled

September 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

November 16, 2010

Status Verified

November 1, 2010

Enrollment Period

6 months

First QC Date

September 15, 2009

Last Update Submit

November 15, 2010

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Adverse event frequency and intensity

    1 month

Secondary Outcomes (2)

  • Plasma levels of ELB353

    1 month

  • Inflammatory transmitter response ex vivo

    2 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

ELB353

EXPERIMENTAL
Drug: ELB353

Interventions

PlaceboDRUG

Oral, 10 days

Placebo
ELB353DRUG

Oral, 10 days

ELB353

Eligibility Criteria

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

You may qualify if:

  • Healthy

You may not qualify if:

  • Concomitant medication
  • Concomitant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biotie investigational site

Berlin, State of Berlin, 14050, Germany

Location

Study Officials

  • Antero Kallio, MD

    Biotie Therapies Corp.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 16, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

November 16, 2010

Record last verified: 2010-11

Locations

DE(1)