Clinical Trials Logo

Clinical Trial Summary

The purpose of the study is to determine the mass balance recovery in expired air, urine and faeces after a single oral dose of 400 mg 14C-labeled BIA 5-1058; to provide plasma, urine and faecal samples for metabolite profiling and structural identification; and determine the routes and rates of elimination of [14C]-BIA 5-1058


Clinical Trial Description

This is a Phase 1, single-dose, single-centre, single period, open-label, absorption, distribution, metabolism and excretion study in 8 healthy adult male subjects. Subjects will receive a single oral dose of 400 mg [14C]-BIA 5-1058, containing not more than (NMT) 4.6 MBq (124 µCi) 14C, as an oral capsule. 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 morning of Day -1 prior to investigational medicinal product (IMP) administration. Subjects will be dosed on the morning of Day 1 after an overnight fast of at least 10 hours and will remain resident in the clinic until up to 336 h after dosing (up to Day 15). Blood, urine, faeces and expired air will be collected at predefined time points for mass balance and PK analysis. It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90% or if <1% of the dose administered has been collected in urine, faeces and expired air within 2 separate, consecutive 24 h periods. This may result in the subjects being discharged as a group prior to completion of the planned residency period. Once the discharge criteria or the planned residency period has been achieved, collection of all samples (blood, urine, faeces, and expired air) will be stopped and the subjects will undergo discharge assessments. Subjects who have not met the mass balance discharge criteria on Day 15 will return to the clinical unit for up to five further 24-hour residency periods (Days 21-22 [±1 day], 28-29 [±1 day], 42-43 [±2 days], 56-57 [±2 days] and 77-78 [±3 days]) to collect blood samples for PK analysis and urine and faeces samples for analysis of total radioactivity. If the parent and metabolite are below the limit of quantification at any of these visits, subsequent return visits may be cancelled. If by Day 78, levels are not below the limit of quantification or if the additional 24 h residency periods are not considered appropriate or necessary, then home collections of urine and/or faeces may be requested at the discretion of the investigator for individual subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04069130
Study type Interventional
Source Bial - Portela C S.A.
Contact
Status Completed
Phase Phase 1
Start date January 22, 2019
Completion date May 2, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Recruiting NCT04417387 - The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
Not yet recruiting NCT06211361 - Cardiac Rehabilitation Program in Patients With Cardiovascular Disease N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04514445 - The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Completed NCT03680638 - The Effect of Antioxidants on Skin Blood Flow During Local Heating Phase 1
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Completed NCT04083872 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting) Phase 1
Completed NCT04083846 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed) Phase 1
Completed NCT03619148 - The Incidence of Respiratory Symptoms Associated With the Use of HFNO N/A
Completed NCT03466333 - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia Phase 2
Completed NCT03693365 - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT05132998 - Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)