Safety and Pharmacokinetics of ELB353 in Healthy Men

This study has been completed.
Sponsor:
Information provided by:
Biotie Therapies Corp.
ClinicalTrials.gov Identifier:
NCT00977886
First received: September 15, 2009
Last updated: November 15, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: Placebo
Drug: ELB353
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Biotie Therapies Corp.:

Primary Outcome Measures:
  • Adverse event frequency and intensity [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma levels of ELB353 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Inflammatory transmitter response ex vivo [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Oral, 10 days
Experimental: ELB353 Drug: ELB353
Oral, 10 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Concomitant medication
  • Concomitant disease
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977886

Locations
Germany
Biotie investigational site
Berlin, Germany, 14050
Sponsors and Collaborators
Biotie Therapies Corp.
Investigators
Study Director: Antero Kallio, MD Biotie Therapies Corp.
  More Information

No publications provided

Responsible Party: CMO, Biotie Therapies Corp.
ClinicalTrials.gov Identifier: NCT00977886     History of Changes
Other Study ID Numbers: BTT70-CD018
Study First Received: September 15, 2009
Last Updated: November 15, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on September 18, 2014