Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 5-1058

PHASE1CompletedINTERVENTIONAL
Enrollment

157

Participants

Timeline

Start Date

May 28, 2018

Primary Completion Date

March 18, 2019

Study Completion Date

March 18, 2019

Conditions
Cardiovascular Disease+Pulmonary DiseasePulmonary Arterial Hypertension
Interventions
DRUG

BIA 5-1058

"25 mg and 100 mg tablets; Oral, once-daily, from Day 1 to Day 10. In Cohorts 1, 3, 5, 7 and 9 (fasted), BIA 5-1058 will be orally administered in the morning after a minimum of 8 h fast. Subjects will remain fasted until 4 h post-dose and will receive lunch approximately 4 h after dosing.~In Cohorts 2, 4, 6, 8 and 10 (fed), BIA 5-1058 will be orally administered in the morning after a moderate breakfast (containing approximately 550 kcal with fat contributing approximately 150 kcal). The meal should be consumed over a maximum period of 25 min, with dosing occurring 30 min after the start of the meal.~Each dose will be administered with 240 mL water."

DRUG

Placebo

"matching placebo tablet; Oral, once-daily, from Day 1 to Day 10. In Cohorts 1, 3, 5, 7 and 9 (fasted), placebo will be orally administered in the morning after a minimum of 8 h fast. Subjects will remain fasted until 4 h post-dose and will receive lunch approximately 4 h after dosing.~In Cohorts 2, 4, 6, 8 and 10 (fed), placebo will be orally administered in the morning after a moderate breakfast (containing approximately 550 kcal with fat contributing approximately 150 kcal). The meal should be consumed over a maximum period of 25 min, with dosing occurring 30 min after the start of the meal.~Each dose will be administered with 240 mL water."

Trial Locations (1)

NG11 6JS

Quotient Sciences, Ruddington

All Listed Sponsors
lead

Bial - Portela C S.A.

INDUSTRY

NCT03708146 - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 5-1058 | Biotech Hunter | Biotech Hunter