NCT02840565

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

A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (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 5-453 after six multiple rising dose regimens of BIA 5-453.

Detailed description

Two centres, double-blind, randomised, placebo-controlled study of six dosage regimens of BIA 5-453 in six groups of healthy male subjects. 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 (including plasma exploratory pharmacokinetics) prior to proceeding to a higher dose level.

Conditions

• Hypertension
• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	BIA 5-453	Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
DRUG	Placebo	The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2016-07-21
• Last updated: 2016-07-21