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Safety and Pharmacokinetics of ELB353 in Healthy Men

NCT ID: NCT00977886

Last Updated: 2010-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral, 10 days

ELB353

Group Type EXPERIMENTAL

ELB353

Intervention Type DRUG

Oral, 10 days

Interventions

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Placebo

Oral, 10 days

Intervention Type DRUG

ELB353

Oral, 10 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy

Exclusion Criteria

* Concomitant medication
* Concomitant disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Biotie Therapies Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Biotie Therapies Corp.

Principal Investigators

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Antero Kallio, MD

Role: STUDY_DIRECTOR

Biotie Therapies Corp.

Locations

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Biotie investigational site

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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BTT70-CD018

Identifier Type: -

Identifier Source: org_study_id