NCT02151994

Safety, Tolerability, Pharmacokinetic, Including Food Interaction, and Pharmacodynamic Profile of BIA 5-1058.

A Double-blind, Randomised, Placebo-controlled, Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetic, Including Food Interaction, and Pharmacodynamic Profile of BIA 5-1058, in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to to assess the safety and tolerability of BIA 5 1058 after single and multiple oral doses

Detailed description

This was a Phase 1, double blind, randomised, placebo-controlled combined single ascending dose (SAD), including food interaction (food effect, FE) analysis, and multiple ascending dose (MAD) study. SAD: This part consisted of an eligibility screening period, one study period involving administration of single doses of BIA 5-1058 or placebo according to a randomized design, and a follow-up period. Nine sequential groups of 8 healthy young male subjects were dosed. Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo. In this first-in-human study, the subjects participating at the lowest dose level of 5 mg were dosed according to a sentinel dosing design to ensure optimal safety. Initially, 2 subjects were dosed; 1 subject with BIA 5-1058 and 1 subject with placebo. After the safety and tolerability results of the first 24 h following dosing for the initial subjects had been found to be acceptable to the MI, the other 6 subjects of the lowest dose level were dosed. MAD: This part consisted of an eligibility screening period, one study period involving administration of multiple doses of BIA 5-1058 or placebo once daily for 10 days, and a follow-up period. Five sequential groups of 8 healthy young male subjects were dosed. Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo. The starting dose of 50 mg was chosen taking into consideration the dose range of the previous SAD sequential groups and was approved by the IEC. Escalation to the next higher dose and the determination of the next dose level was based on safety, tolerability and available PK results of the previously administered dose FE: This part consisted of an eligibility screening period, an open-label two-way crossover study period, and a follow-up period. One group of 12 subjects received single doses of 400 mg BIA 5-1058 during 2 treatment periods, once after having fasted overnight and once after consumption of a high fat breakfast. Each treatment was separated by a period of at least 7 days. The treatment sequence was determined by randomisation.

Conditions

• Hypertension and Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	BIA 5-1058	oral administration
DRUG	Placebo	oral administration

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2014-06-02
• Last updated: 2016-01-05
• Results posted: 2016-01-05

Locations

1 site across 1 country: Netherlands