NCT03099226

Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Dose Regimens of BIA 5-453

A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Dose Regimens of Etamicastat (BIA 5-453) in Hypertensive Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to characterise the plasma and urine pharmacokinetic profile of Etamicastat (BIA 5-453) and its metabolites after three multiple rising dose regimens of Etamicastat (BIA 5-453).

Detailed description

Single centre, double-blind, randomised, placebo-controlled study of three dosage regimens of Etamicastat (BIA 5-453) in 3 groups of 8 hypertensive patients. In each group, the study consisted of a 10-day multiple-dose period. Progression to the next dose level only occurred if the previous dose level was considered to be safe and well tolerated. An appropriate interval separated the investigation of doses to permit a timely review and evaluation of safety data prior to proceeding to a higher dose level.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Placebo	Placebo blue hard gelatine capsules
DRUG	BIA 5-453	Etamicastat (BIA 5-453) blue hard gelatine capsules - 50 Strength (mg)

Timeline

• Start date: 2008-07-15
• Primary completion: 2009-04-03
• Completion: 2009-04-03
• First posted: 2017-04-04
• Last updated: 2017-04-04

Locations

1 site across 1 country: France