A Mass Balance Study
Research type
Research Study
Full title
A Phase I, Two-part, Open-label, Non-randomised Study to Investigate the Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects
IRAS ID
183793
Contact name
Jim Bush
Contact email
Sponsor organisation
Debiopharm International SA
Eudract number
2015-002604-87
Duration of Study in the UK
0 years, 2 months, 24 days
Research summary
Debio 1450 is an investigational medicinal product being developed to treat antibiotic resistant staphylococcal bacterial infection. Debio 1450 itself presents very limited antibacterial activity, but after administration, Debio 1450 will be converted to more potent Debio1452 in the body. A targeted antibiotic agent such as Debio 1452 is unlikely to cause the substantial changes in normal gut flora so commonly seen after use of most antibiotics used in clinical practice today.
As of 27th May 2015, Debio 1450 has been investigated in 132 healthy subjects in three studies, the highest doses being 800 mg (single oral dose) or 320 mg (single intravenous dose). The highest oral and intravenous dose administration over 5 days was at 320 mg BID and 240 mg BID, respectively.
Determining mass balance recovery (the amount of drug recovered after administration) and identification of major metabolites (breakdown products of a drug in body) of Debio 1450 is required as an integral part of drug development. Therefore, this study has been designed to characterise the absorption, distribution, metabolism (the way body handles the drug), and excretion profile of Debio 1450, following single administration of 14C-Debio 1450 by both oral and intravenous routes, which are the routes intended for therapeutic use.
Considering the large structure of the drug to allow for adequately capturing Debio 1450 metabolism, administration will proceed with the drug with radioactive carbon attached at 2 different sites, position 1 in Part A, and position 25 in Part B.
This study involves two parts, in part A one cohort will receive a single 2 hour IV infusion of 14C Debio 1450 and the other cohort will receive a single oral dose of 14C Debio 1450 solution. In part B subjects will receive a single oral dose of Debio 1450 containing a microtracer dose (1/100th of the dose given in Part A) of 14C Debio 1450.
The effective radiation dose received by the volunteers in Part A of this study is defined as being within dose limits for members of the public with a minor associated risk. The effective radiation dose received by the volunteers in Part B of this study is defined as being within variations of natural background with a trivial associated risk.
The amount of radioactive material administered to the volunteers is typical for this type of clinical trial and is necessary to be able to determine the levels of metabolites (drug breakdown products) in urine and faeces in order to achieve the objectives of the study.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0514
Date of REC Opinion
1 Sep 2015
REC opinion
Further Information Favourable Opinion