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.

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. - BIA 5-1058 SAD/MAD study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36800

Enrollment

108

Registered

2010-12-30

Start date

2011-03-22

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

verhoogde bloeddruk Hypertension and Chronic Heart Failure

Interventions

SAD In each group subjects will receive a single dose of the study compound (n=6) or matching placebo (n=2) on Day 1 FOOD INTERACTION The subjects will receive a single dose of the study compound on

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)