NCT04991155

Effect of Food on BIA 5-1058

Effect of Food on BIA 5-1058 Bioavailability in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the effect of food on the pharmacokinetic (PK) profile of BIA 5-1058 after a single dose in healthy subjects.

Detailed description

Single-centre, open-label, randomised, single-dose, three-way crossover, three-part study in 54 healthy subjects. Duration of treatment: The study comprised a screening evaluation between 2 and 28 days before the first IMP (Investigational Medicinal Product) administration and 3 treatment periods of approximately 4 days, separated by wash-out periods of at least 7 days. A follow-up visit was performed approximately 7 days after discharge from the last period or early discontinuation. For each subject, the full duration of the participation in the study was approximately 9 weeks.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	BIA 5-1058	BIA 5-1058 (tablets 100 mg) was administered orally with 240 mL (Part 1) or 270 mL (Part 2 and Part 3) of water, in one period in the morning under fasting conditions (after at least a 10-hour overnight fast), in one period in the morning after a moderate meal, and in the other period at lunch after a moderate meal.

Timeline

• Start date: 2015-07-20
• Primary completion: 2015-09-22
• Completion: 2015-09-22
• First posted: 2021-08-05
• Last updated: 2021-08-05