Phase 1 bioavailability study in healthy subjects (QSC118018)
Research type
Research Study
Full title
A Phase 1, single-center, open-label, two-period, one-sequence, single dose study to determine the absolute bioavailability of sotagliflozin in healthy male and female subjects
IRAS ID
249999
Contact name
Anne-Frederique Ghuysen
Contact email
Sponsor organisation
Sanofi-aventis Recherche & Développement
Eudract number
2017-004937-94
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 22 days
Research summary
The Sponsor is developing the test medicine, Sotagliflozin, for the potential treatment of type 1 and type 2 diabetes mellitus. Diabetes mellitus causes the level of glucose (sugar) in the blood to become too high. Type 1 diabetes happens when the body can't produce enough of a hormone called insulin which controls blood sugar. Type 2 diabetes is often associated with age and being overweight, and is caused by the body becoming insensitive to the hormone insulin.
The study will try to see exactly how much of the test medicine gets into the blood stream when given as a tablet and a dose through a vein in the arm. Some of the doses in this study will contain a very small amount of Carbon-14, which is a type of naturally occurring radioactivity that allows us to trace the test medicine in the blood and assess how much is being taken up into the body.
The study will enrol up to 6 healthy volunteers who will attend the clinical unit on two occasions for two study periods. In Period 1, the volunteers will receive a dose of the test medicine as 2 tablets, after this dose the volunteers will be given a dose of the test medicine directly into the vein. Volunteers will be discharged on Day 8 and there will be a break of at least 10 days before the volunteers return for Period 2. In Period 2, volunteers will be given the test medicine as 2 tablets and then receive a dose directly into the vein as in Period 1, the volunteers will also receive a charcoal drink at regular times during the study visit. Volunteers will be discharged on Day 8 and will return for a follow up visit 12 – 16 days after their last dose.
REC name
HSC REC A
REC reference
18/NI/0235
Date of REC Opinion
7 Jan 2019
REC opinion
Further Information Favourable Opinion