NCT04675944

Effect of BIA 5-1058 on the Steady State Pharmacokinetics of Treprostinil

An Open-Label, Three Period, Fixed Sequence Study to Assess the Effect of a Single Dose of BIA 5 1058 200 mg on the Steady State Pharmacokinetics of Treprostinil in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effect of BIA 5-1058 200 mg on the pharmacokinetic (PK) of treprostinil

Detailed description

This study was an open-label, three period, fixed sequence study in healthy male and female subjects performed at a single study center. The study comprised: * Screening during Days -28 to -2 (both inclusive). * Three treatment periods separated by a washout period of at least 10 days.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	BIA 5-1058	200 mg (2 x 100 mg tablets), oral route
DRUG	treprostinil	1 mg (1 extended-release tablet), oral route

Timeline

• Start date: 2018-02-28
• Primary completion: 2018-05-25
• Completion: 2018-05-25
• First posted: 2020-12-19
• Last updated: 2020-12-19

Locations

1 site across 1 country: Germany