Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
14C-microtracer · 1 trial · 2 indications
Absolute Bioavailability (F) will be a composite endpoint and include Area under plasma concentration (AUC) dose normalized for intravenous (IV) 14C-IMP AUClast dose normalized for oral Investigational Medicinal Product (IMP)
| Arm | Type | Description |
|---|---|---|
| Sotagliflozin | EXPERIMENTAL | One treatment period includes a single oral dose of sotagliflozin + IV microdose 14C-sotagliflozin tracer plus charcoal. The other treatment period includes a single oral dose of sotagliflozin + IV microdose 14C-sotagliflozin tracer without charcoal. |
| Name | Type | Description |
|---|---|---|
| Sotagliflozin (SAR439954) | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
| 14C-microtracer | DRUG | Pharmaceutical form: Solution for injection Route of administration: Intravenous |
| Charcoal | DRUG | Pharmaceutical form: Granules for suspension Route of administration: Oral |
Inclusion criteria : * Male or female subjects, between 18 and 55 years of age, inclusive. * Body weight between 50.0 and 120.0 kg, inclusive, if male, and between 40.0 and 100.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. BMI between 30.0 and 32.0 is acc...