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

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

June 11, 2018

Primary Completion Date

September 7, 2018

Study Completion Date

September 7, 2018

Conditions
Pulmonary Arterial Hypertension
Interventions
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.

Trial Locations (1)

CF48 4DR

Simbec Research Ltd (Simbec), Merthyr Tydfil

All Listed Sponsors
lead

Bial - Portela C S.A.

INDUSTRY

NCT07173738 - Pharmacokinetics, Safety and Tolerability of Concurrent Doses of BIA 5-1058 and Furosemide | Biotech Hunter | Biotech Hunter