NL-OMON45578
Completed
Not Applicable
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> - 14C-BIA 5-1058 human ADME and mass balance study
Bial Portela & Ca.0 sites8 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- cardiovascular diseases
- Sponsor
- Bial Portela & Ca.
- Enrollment
- 8
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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