Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites
The purpose of this study is to:
To determine the rate and routes of excretion of BIA 5-453 and the mass balance in urine and faeces
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 5-453 and Metabolites Following a Single-dose Oral Administration|
- urinary excretion of BIA 5-453 associated radioactivity [ Time Frame: pre-dose, then it was collected from 0-4, 4-8, 8-24, 24-48, 48-72, 72-120, 120-168, 168-216, and 216-264 hours post-dose. ] [ Designated as safety issue: No ]following a single 600 mg oral dose labeled with 98 μCi of [14C]
- faecal excretion of BIA 5-453 associated radioactivity [ Time Frame: following a single 600 mg oral dose labeled with 98 μCi of [14C] ] [ Designated as safety issue: No ]baseline period. Following dose, each faeces sample was collected during the 264 hours post-dose period.
- amount of BIA 5-453 associated radioactivity present in the expired air [ Time Frame: baseline, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h 6h, 8h, 12h and 24h post-dose ] [ Designated as safety issue: No ]following a single 600 mg oral dose labeled with 98 μCi of [14C]
|Study Start Date:||September 2008|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Single administration. 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 50 mg, hard gelatina capsules
Each subject will receive a single oral dose of 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 (600 mg).
Monocentre, open, non-placebo-controlled, single-group, single-dose study Safety measurements (12-lead ECG, vital signs, blood chemistry and haematology) will be conducted before and after the study, adverse events will be monitored throughout the study.
Subjects should be hospitalized the day before the administration until 264 hours thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03014375
|Swiss Pharma Contract Ltd.|
|Allschwil, Switzerland, CH-4123|