A Phase 1, food effect, bioavailability study of Sotagliflozin
Research type
Research Study
Full title
A phase 1, randomized, single-center, open-label, three-sequence, three-period, three-treatment crossover study to evaluate the effect of food on the single-dose pharmacokinetics of 400 mg sotagliflozin (2 x 200 mg tablets) and to explore the relative bioavailability of 400 mg sotagliflozin (2 x 200 mg tablets) to 400 mg oral solution in healthy male and female subjects
IRAS ID
223324
Contact name
Firas Almazedi
Contact email
Sponsor organisation
Sanofi-aventis Recherche & Developpement
Eudract number
2016-004650-15
Clinicaltrials.gov Identifier
REC number , 17/EE/0066
Duration of Study in the UK
0 years, 2 months, 11 days
Research summary
Sotagliflozin is a new drug that has been developed as a potential treatment for diabetes. Diabetes is a serious condition and despite there being a number of treatment options available, there is still a need for safe and effective treatments.
The study drug (sotagliflozin) is known to block the uptake of glucose in the stomach and cause the body to excrete glucose in urine, therefore reducing blood glucose levels. This treatment has presented a promising alternative to insulin injections in diabetic patients and hopefully will be a simpler and a more effective treatment.
In this study, sotagliflozin will be studied as two different formulations: a tablet and an oral solution.
Fifteen healthy male and female participants will be participating in this study. This study is being conducted at 1 site (our Unit) only.
The study will be split into 3 sequences.
Five participants will take part in each sequence. The duration of all of the sequences will be the same for each (up to 12 weeks).
In each sequence participants will take part in 3 treatment periods where they will receive a single dose of the study drug on 3 separate occasions (Day 1 of each treatment period).There will be up to 21 days between each dosing occasion.
On one dosing occasion participants will receive 400 mg of the study drug after having eaten a high fat breakfast.
On the other dosing occasion participants will receive 400 mg of the study drug after an overnight fast of approximately 10 hours.
And on the final dosing occasion participants will receive 400 mg of the study drug as an oral solution after an overnight fast of approximately 10 hours.
These dosing occasions can be in different orders.
Subject participation is expected to last up to 12 weeks from the time of screening till the last post-study visit.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0066
Date of REC Opinion
9 May 2017
REC opinion
Further Information Favourable Opinion