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.

Completed

• Conditions: verhoogde bloeddruk; Hypertension and Chronic Heart Failure; 10019280

• Registration Number: NL-OMON36800
• Lead Sponsor: Bial Portela & Ca.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 108

Inclusion Criteria

Healthy male, 18 - 55 years, BMI 18.0 - 30.0 kg/m2.

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics:<br /><br>plasma and urine BIA 5-1058 & metabolites concentrations; PK parameters in<br /><br>plasma for SAD and food interaction parts: Cmax, tmax, kel, t*, AUClast,<br /><br>AUCinf, Fr (food interaction part only), Vz/F, CL/F, CLr; MAD part, Day 1:<br /><br>Cmax, tmax, AUC0-tau; MAD part, Day 10: Cmax, tmax, AUC0-tau, kel, t*, Vz/F,<br /><br>Cmin, Rac, Ctrough; in urine (SAD and MAD parts only): Ae, Ae %dose.<br /><br>Pharmacodynamics:<br /><br>plasma D*H activity and urine NE, DA, DOPAC and HVA concentrations; PD<br /><br>parameters of D*H activity inhibition in plasma in SAD and MAD parts: Emax,<br /><br>tEmax, AUEC.<br /><br>Safety:<br /><br>AEs, vital signs, 12-lead ECG; clinical laboratory, physical examination,<br /><br>telemetry</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>