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Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202

NCT02763787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2016-05-16

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety and tolerability of single oral rising doses of BIA 3-202 up to 800 mg (proposed doses 10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg and 800 mg) in groups of 9 healthy male adult subjects, to characterise the preliminary pharmacokinetics of single rising oral doses of BIA 3-202 in healthy male adult subjects, to investigate the effects of single doses of BIA 3-202 on COMT activity in human erythrocytes and to investigate the effect of food on the pharmacokinetics of a single dose of BIA 3-202.

Conditions

Interventions

DRUG

BIA 3-202

single rising oral doses (10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg, 800 mg)

DRUG

Placebo

Identical placebo

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-04-30
Primary Completion
2000-06-30
Completion
2000-06-30

Countries

  • United Kingdom

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02763787 on ClinicalTrials.gov