AME of BNZ in healthy male subjects
Research type
Research Study
Full title
A Phase I, Open-label, Study of the Absorption, Metabolism and Excretion, of [14C]-Benznidazole (BNZ) Following a Single Oral Dose in Healthy Male Subjects
IRAS ID
242220
Contact name
Sunu Valasseri
Contact email
Sponsor organisation
Exeltis France
Eudract number
2017-003870-15
Duration of Study in the UK
0 years, 1 months, 12 days
Research summary
Benznidazole (BNZ) is an already established antiprotozoal (drugs that fight parasitic infections), this drug is the first line drug for the treatment of a parasitic infection by an organism called Trypanosoma cruzi that causes Chagas disease. The sponsor has developed two new oral formulations of the drug.
The purpose of this trial is to determine the absorption (how the drug gets into the body), metabolism (how the drug is broken down) and excretion (removal of drug by the body) of Benznidazole and to characterize the metabolites (breakdown products) present in blood, urine and faeces in healthy male subjects following a single oral radiolabelled dose of 100mg Benznidazole.
Subjects will be admitted to the Clinical Research Unit on Day-1 and be confined to the unit until at least Day 11 or as late as Day 15, based on the recovery of radioactivity from their urine and faeces. A single oral dose of Benznidazole will be given on Day 1. Subjects will be discharged on Day 11 if all the following discharge criteria are met: >90% of radioactivity recovered and <1% of the total administered activity is recovered in combined excreta (urine and faeces) in 2 consecutive 24-hour periods. If discharge criteria are not met by Day 11, subjects will remain in the unit up to a maximum of Day 15. If the discharge criteria have not been met by Day 15, subjects may be asked to attend up to 2 additional visits on a non-residential basis on Days 21 and 28 for collection of 24-hour excreta samples (urine and faeces).REC name
North East - York Research Ethics Committee
REC reference
18/NE/0055
Date of REC Opinion
11 May 2018
REC opinion
Favourable Opinion