NCT02772614

Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites

An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites Following a Single-dose Oral Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Male
• Age: 40 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is: To determine the rate and routes of excretion of BIA 3-202 and the mass balance in urine and faeces To determine the kinetics of total radioactivity in blood To determine the kinetics of total radioactivity in plasma To determine the kinetics of BIA 3-202 and its metabolites in plasma

Detailed description

Monocentre, open, non-placebo-controlled, single-group, single-dose study. Safety measurements (12-lead ECG, vital signs, blood chemistry and haematology) were conducted before and after the study, adverse events were monitored throughout the study. Each subject was to receive a single oral dose of 2.5 MBq \[14C\]-labelled BIA 3-202 (200 mg). This was the intended radiolabelled dose without any losses; the actual administered dose was of 2.29 MBq \[14C\]-labelled BIA 3-202 (200 mg). Subjects were hospitalized the day before the administration until 264 hours thereafter. Whole blood samples (2 mL) for total radioactivity analysis, plasma samples (1.5 mL) for total radioactivity analysis, and plasma samples (7 mL) for analysis of BIA 3-202 and its metabolites were collected at the following times: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose. Urine was sampled before the drug administration (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. Aliquots of each sample were taken for liquid scintillation counting by the investigator. Aliquots were separated for determination of parent drug and metabolite patterns. A baseline faeces sample was obtained during the screening or baseline period. Following dose, each faeces sample was collected in a separate container during the 264 hours post-dose period. Vomitus (if produced) was collected.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	BIA 3-202 (200 mg)	200 mg powder for oral use of unlabelled BIA 3-202

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2016-05-13
• Last updated: 2016-05-13

Locations

1 site across 1 country: Switzerland