NCT03119194

Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067

An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose is to and to assess the mass balance recovery after a single oral dose of \[14C\]-BIA 9-1067 and to provide plasma, urine and faecal samples for metabolite profiling and structural identification.

Detailed description

This is an open-label, single-dose, single-period, non-randomised study in healthy male subjects. Subjects will be screened for eligibility to participate in the study between 28 and 2 days before dosing. Eligible subjects will be admitted to the clinical unit on the evening of the day before dosing (Day -1). Subjects will be dosed on the morning of Day 1 following an overnight fast of approximately 8 h. Blood, urine, faeces and expired air will be collected at predefined time points for mass balance and PK analysis. Subjects will remain resident in the clinic until the morning of Day 22, when they will be discharged as a group. Single dose administration on a single occasion. The estimated duration of the study from screening until the final return visit is approximately 3.5 months.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	[14C]-BIA 9-1067	1 × 100 mg capsule, Oral

Timeline

• Start date: 2017-01-27
• Primary completion: 2017-04-27
• Completion: 2017-04-27
• First posted: 2017-04-18
• Last updated: 2017-08-24

Locations

1 site across 1 country: United Kingdom