An open-label study to assess the absorption, distribution, metabolism and excretion, including the mass balance of [14C] labeled BIA 5-1058 and metabolites following a single oral dose administration in healthy male subjects

An open-label study to assess the absorption, distribution, metabolism and excretion, including the mass balance of [14C] labeled BIA 5-1058 and metabolites following a single oral dose administration in healthy male subjects - 14C-BIA 5-1058 human ADME and mass balance study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45578

Enrollment

Registered

2017-04-13

Start date

2017-03-31

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

cardiovascular diseases

Interventions

The volunteer will receive a single dose of 400 mg radiolabeled BIA 5 1058 in the form of 3 oral capsules.

ADME

BIA 5-1058

Cardiovascular diseases

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy male subjects 18-65 years old, inclusive (of which at least 2 subjects of *55 years of age) Body mass index: 18.0-30.0 kg/m2, inclusive, at screening

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, HIV/AIDS. Donation or loss of more than 100 mL of blood within 90 days prior to drug administration. Donation or loss of more than 1.5 liters of blood in the 10 months prior to drug administration in the current study. Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year prior to screening.

Design outcomes

Primary

Measure	Time frame
to determine the rate and routes of excretion of BIA 5-1058 and the mass balance in urine, feces and exhaled air, after a single oral dose of 400 mg 14C-labeled BIA 5-1058 containing 3.7 MBq of radiocarbon to determine the pharmacokinetics (PK) of total radioactivity in plasma and whole blood and to assess the blood-to-plasma ratio to determine the PK of BIA 5-1058 and its metabolites in plasma	—

Secondary

Measure	Time frame
to identify and quantify the BIA 5-1058 metabolites in plasma, urine and feces to identify the biotransformation pathways of BIA 5-1058 in humans to evaluate the absorption of BIA 5-1058 to evaluate the single oral dose tolerability of the formulation of 400 mg BIA 5-1058, containing 3.7 MBq of 14C-BIA 5-1058 to assess the safety and tolerability of BIA 5-1058	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)