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<br>
Completed
- Conditions
- 1008220610047066cardiovascular diseases
- Registration Number
- NL-OMON45578
- Lead Sponsor
- Bial Portela & Ca.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>to determine the rate and routes of excretion of BIA 5-1058 and the mass<br /><br>balance in urine, feces and exhaled air, after a single oral dose of 400 mg<br /><br>14C-labeled BIA 5-1058 containing 3.7 MBq of radiocarbon<br /><br>to determine the pharmacokinetics (PK) of total radioactivity in plasma and<br /><br>whole blood and to assess the blood-to-plasma ratio<br /><br>to determine the PK of BIA 5-1058 and its metabolites in plasma</p><br>
- Secondary Outcome Measures
Name Time Method <p>to identify and quantify the BIA 5-1058 metabolites in plasma, urine and feces<br /><br>to identify the biotransformation pathways of BIA 5-1058 in humans<br /><br>to evaluate the absorption of BIA 5-1058<br /><br>to evaluate the single oral dose tolerability of the formulation of 400 mg BIA<br /><br>5-1058, containing 3.7 MBq of 14C-BIA 5-1058<br /><br>to assess the safety and tolerability of BIA 5-1058</p><br>