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OpenTrials
Completed

NCT Number: NCT00977886

Safety and Pharmacokinetics of ELB353 in Healthy Men

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Biotie investigational site

Berlin, State of Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy

Exclusion criteria

  • Concomitant medication
  • Concomitant disease

Treatment and study plan

Placebo

Drug

Oral, 10 days

ELB353

Drug

Oral, 10 days

Primary outcomes

  1. Adverse event frequency and intensity

    Time frame: 1 month

Secondary outcomes

  1. Plasma levels of ELB353

    Time frame: 1 month

  2. Inflammatory transmitter response ex vivo

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Biotie Therapies Corp.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2009
Registry last updated
Nov 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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