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Effect of Age-gender on the Pharmacokinetic and Pharmacodynamic Profiles of BIA 5 1058

Pulmonary Arterial Hypertension Clinical Trial

Official title:
Effect of Age-gender on the Pharmacokinetic and Pharmacodynamic Profiles of BIA 5 1058. An Open-label, Parallel Group, Multiple Dose 10-day Study.

Clinical Trial Summary

the purpose of this study is to determine the effect of age on the Pharmacokinetics (PK) profile of BIA 5-1058 at steady state after multiple oral doses

Clinical Trial Description

This was a single-centre, open-label, parallel group, non-randomised, two-part multiple dose 10-day study in healthy young and elderly male and female subjects. The study comprised a screening evaluation between 2 and 28 days before the first Investigational Medicinal Product (IMP) administration, a hospitalisation period of 15 days comprising a treatment period of 10 days, and a follow-up visit approximately 7 days after discharge. Part 1: Subjects received 1200 mg of BIA 5-1058 once a day (od), in fasting conditions, for 10 days Part 2 : Subjects received 400 mg of BIA 5-1058 od, in fasting conditions, for 10 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04991194
Study type Interventional
Source Bial - Portela C S.A.
Contact
Status Terminated
Phase Phase 1
Start date October 12, 2015
Completion date December 30, 2016
View Details
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