Absolute Oral Bioavailability of SAR439859 in Volunteers (QSC204017)
Research type
Research Study
Full title
A Phase 1, open-label, single center, one period, one sequence study to determine absorption, metabolism, and excretion of a single oral dose administration of radiolabeled 14C-SAR439859 and an assessment of the absolute oral bioavailability using the microdosing technique in healthy post-menopausal women.
IRAS ID
292755
Contact name
Clinical Study Director - Virginie Esposito PhD
Contact email
Sponsor organisation
Sanofi Recherche et Development
Eudract number
2020-004747-91
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 8 days
Research summary
The Sponsor is developing the test medicine, SAR439859, for the potential treatment of breast cancer. Breast cancer is one of the most common types of cancer in the UK and worldwide.
The study will try to identify how the test medicine is taken up, broken down and excreted by the body when given to post-menopausal volunteers aged 40-75. Two of the test medicine formulations (recipes) given to volunteers will be radiolabeled. Radiolabeled means that the test medicine has a radioactive component (carbon-14) which helps us to track where the test medicine is in the body and how it is broken down.
The study will involve one study visit with up to 16 overnight stays. Volunteers will be dosed with the test medicine on 3 occasions. Volunteers will be admitted to the clinic on Day -1. On Day 1, following an overnight fast of at least 10 hours, volunteers will receive an oral dose of the test medicine in the form of a tablet. Three hours after dosing, volunteers will receive a small radiolabeled dose of the test medicine intravenously (into a vein) over 15 minutes. Volunteers will remain in the clinic following dosing and on Day 7, will be given a radiolabeled oral solution of the test medicine.
Volunteers will be required to stay in the clinic until at least Day 11. However, if the required radioactive criteria has not been met, their stay may be extended up to Day 16. From Day 16, volunteers may have to collect urine/faecal samples at home. Volunteers may be required to return to the clinic for up to 4 return visits for assessments and wellbeing monitoring and will be required to return for a follow up visit 7-10 days following their last sample collection or as part of their Day 44 return visit.
REC name
HSC REC B
REC reference
21/NI/0068
Date of REC Opinion
28 May 2021
REC opinion
Further Information Favourable Opinion