NCT01520727

A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects

A Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses.

Detailed description

Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in up to 8 sequential groups of 8 healthy young male subjects.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	BIA 9-1067	single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
DRUG	Placebo	single-dose

Timeline

• Start date: 2007-10-01
• Primary completion: 2007-12-01
• Completion: 2009-04-01
• First posted: 2012-01-30
• Last updated: 2015-01-08
• Results posted: 2015-01-08

Locations

1 site across 1 country: France