NCT07173738

Pharmacokinetics, Safety and Tolerability of Concurrent Doses of BIA 5-1058 and Furosemide

An Open Label, Three Period, Fixed Sequence Study to Assess the Pharmacokinetics, Safety and Tolerability of Concurrent Doses of BIA 5-1058 and Furosemide in Healthy Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is: * To assess the effect of BIA 5 1058 400 mg on furosemide pharmacokinetics (PK). * To assess the effect of furosemide 40 mg on the PK of BIA 5 1058.

Detailed description

This was an open-label, single-dose, fasted, 3-periods, fixed-sequence study separated by a washout period of 10 days or more in healthy volunteers. Each healthy subject will participate in the study for approximately 3 months, including a 28-day screening period, 3 periods of 3.5 days and 4 nights (inpatient) with each dosage separated by a 10 day washout period and a follow-up visit. The inpatient period will be from Day -1 to Day 4 morning. Dosing will occur on Day 1 and subjects will remain in the clinic until 72 hours (h) after administration. A Follow up visit will be performed 14 ± 2 days after discharge of the last period.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	BIA 5-1058	During treatment period 1, a single oral dose of BIA 5-1058 (400 mg) will be administered on the morning of day 1, following an overnight fast of at least 10 h.
DRUG	Furosemide	During treatment period 2, a single oral dose of furosemide (40 mg) will be administered on the morning of day 1, following an overnight fast of at least 10 h.
DRUG	BIA 5-1058 and Furosemide	During treatment period 3, a single oral dose of both investigational medicinal product (IMPs) BIA 5-1058 (400 mg) concomitantly with furosemide (40 mg) will be administered on the morning of day 1, following an overnight fast of at least 10 h.

Timeline

• Start date: 2018-06-11
• Primary completion: 2018-09-07
• Completion: 2018-09-07
• First posted: 2025-09-15
• Last updated: 2025-09-15

Locations

1 site across 1 country: United Kingdom