NCT04994119

Effect of BIA 5-1058 400 mg on Warfarin Pharmacokinetics

An Open-label, Three Period, Fixed Sequence Study to Assess the Effect of a Single Dose of BIA 5 1058 400 mg on Warfarin Pharmacokinetics in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (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 investigate CYP2C9 inhibition by BIA 5-1058 through the assessment of its effect on the Pharmacokinetic (PK) of S-warfarin, a substrate of CYP2C9. * To assess the effect of warfarin on the PK of BIA 5-1058.

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. Duration of Treatment: The duration of participation for each subject was approximately 2 months and 2 weeks (including the screening period).

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	BIA 5-1058	Oral BIA 5-1058 (Zamicastat) 100 mg tablets
DRUG	Warfarin	Oral Warfarin (Coumadin) 5 mg film coated tablets

Timeline

• Start date: 2018-02-23
• Primary completion: 2018-05-23
• Completion: 2018-05-23
• First posted: 2021-08-06
• Last updated: 2021-08-06

Locations

1 site across 1 country: Germany