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...
14C-microtracer is a carbon-14 labeled small molecule tracer developed by Sanofi. It is used in clinical research to study the bioavailability and metabolism of drugs, including sotagliflozin, in healthy volunteers. The tracer is administered in microdoses to track how a drug is absorbed and processed in the body.
14C-microtracer is used in Type 2 Diabetes Mellitus research to determine the bioavailability of sotagliflozin, a drug candidate for the condition. It helps quantify how much of the drug reaches systemic circulation after oral administration. The tracer itself is not a treatment but a research tool.
14C-microtracer is developed by Sanofi, a global pharmaceutical company traded on the New York Stock Exchange under the ticker SNY. Sanofi uses this tracer in clinical pharmacology studies to characterize the pharmacokinetics of its drug candidates.
14C-microtracer has been studied in a Phase 1 clinical trial. It is an investigational research agent and is not approved by the FDA for any indication. The Phase 1 trial has been completed.
14C-microtracer was evaluated in a single Phase 1 trial, NCT03802487, titled "Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects." The trial enrolled 6 healthy volunteers in the United Kingdom and has been completed. It was an uncontrolled study without randomization or blinding.