Safety and Pharmacokinetics of ELB353 in Healthy Men

Biotie Therapies Corp.48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

PlaceboDRUG

Oral, 10 days

ELB353DRUG

Oral, 10 days

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Exclusion Criteria: * Concomitant medication * Concomitant disease

Locations (1)

Biotie investigational site

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

Adverse event frequency and intensity

Time frame: 1 month

Secondary Outcomes

Plasma levels of ELB353

Time frame: 1 month

Inflammatory transmitter response ex vivo

Time frame: 2 weeks

Data from ClinicalTrials.gov

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