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Safety and Pharmacokinetics of ELB353 in Healthy Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00977886
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : November 16, 2010
Information provided by:
Biotie Therapies Corp.

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Placebo Drug: ELB353 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Oral, 10 days

Experimental: ELB353 Drug: ELB353
Oral, 10 days

Primary Outcome Measures :
  1. Adverse event frequency and intensity [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Plasma levels of ELB353 [ Time Frame: 1 month ]
  2. Inflammatory transmitter response ex vivo [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Concomitant medication
  • Concomitant disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00977886

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Biotie investigational site
Berlin, Germany, 14050
Sponsors and Collaborators
Biotie Therapies Corp.
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Study Director: Antero Kallio, MD Biotie Therapies Corp.
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Responsible Party: CMO, Biotie Therapies Corp. Identifier: NCT00977886    
Other Study ID Numbers: BTT70-CD018
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: November 16, 2010
Last Verified: November 2010