NCT02071810

Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067

A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Four Multiple Rising Dose Regimens of BIA 9-1067 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising dose regimens of BIA 9-1067.

Detailed description

Single centre, double-blind, randomised, placebo-controlled study of four dosage regimens of BIA 9-1067 in four groups of healthy male volunteers. In each group, the study will consist of an once-daily (o.d.) 8-day multiple-dose period. Progression to the next dose level will only occur if the previous dose level was considered to be safe and well tolerated. An appropriate interval (will separate the investigation of doses to permit a timely review and evaluation of safety data prior to proceeding to a higher dose level.

Conditions

• Parkinson's Disease (PD)

Interventions

Type	Name	Description
DRUG	BIA 9-1067
DRUG	Placebo

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2014-02-26
• Last updated: 2015-12-24
• Results posted: 2015-01-09

Locations

1 site across 1 country: France