- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00977886
Safety and Pharmacokinetics of ELB353 in Healthy Men
November 15, 2010 updated by: Biotie Therapies Corp.
A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Oral ELB353 in Healthy Male Volunteers - A Double-Blind, Randomized, Placebo-controlled, Sequential Group Study
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 14050
- Biotie investigational site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- Concomitant medication
- Concomitant disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Oral, 10 days
|
Experimental: ELB353
|
Oral, 10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse event frequency and intensity
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma levels of ELB353
Time Frame: 1 month
|
1 month
|
Inflammatory transmitter response ex vivo
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
September 15, 2009
First Submitted That Met QC Criteria
September 15, 2009
First Posted (Estimate)
September 16, 2009
Study Record Updates
Last Update Posted (Estimate)
November 16, 2010
Last Update Submitted That Met QC Criteria
November 15, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- BTT70-CD018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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