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drugset / Trial / NCT01520727

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

NCT01520727 ↗

Phase 1 Completed 64 enrolled Bial - Portela C S.A.
RandomizedFactorialDouble-blindTreatment

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.

Timeline

Start
2007-10
Primary completion
2007-12
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Opicapone Small molecule 10 mg Oral
Subject Opicapone Small molecule 25 mg Oral
Subject Opicapone Small molecule 50 mg Oral
Subject Opicapone Small molecule 100 mg Oral
Subject Opicapone Small molecule 200 mg Oral
Subject Opicapone Small molecule 400 mg Oral
Subject Opicapone Small molecule 800 mg Oral
Subject Opicapone Small molecule 1200 mg Oral

Indications

Parkinson disease