Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects
- Conditions
- Type 1 Diabetes MellitusType 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03310944
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To assess the relative bioavailability of sotagliflozin following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 versus the reference tablet formulation in fasted conditions in healthy subjects.
Secondary Objectives:
* To assess the pharmacokinetic characteristics of sotagliflozin and its 3-O-glucuronide following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 and of the reference formulation in fasted conditions in healthy subjects.
* To assess the clinical and laboratory safety of single oral doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 and the reference tablet formulation in fasted conditions in healthy subjects.
- Detailed Description
Total duration is 37 to 75 days for each subject, with 2 to 21 days screening period; 4 dosing days, i.e. one in each of the 4 treatment periods. Observation period in each treatment period is 6 days. Washout between dosing days is 7 to 10 days. Follow-up visit is 14-21 days after last dosing.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sotagliflozin dose 1 (reference formulation) sotagliflozin (SAR439954) Single oral dose on Day 1 of one of the four period in fasting condition Sotagliflozin dose 4 (prototype p3 formulation) sotagliflozin (SAR439954) Single oral dose on Day 1 of one of the four period in fasting condition Sotagliflozin dose 2 (prototype p1 formulation) sotagliflozin (SAR439954) Single oral dose on Day 1 of one of the four period in fasting condition Sotagliflozin dose 3 (prototype p2 formulation) sotagliflozin (SAR439954) Single oral dose on Day 1 of one of the four period in fasting condition
- Primary Outcome Measures
Name Time Method Assessment of PK Parameter: Maximum plasma concentration (Cmax) From 0 to 144 hours after IMP intake Sotagliflozin: Maximum plasma concentration (Cmax) for reference, p1, p2, and p3 formulations
Assessment of Pharmacokinetic (PK) Parameter: AUC From 0 to 144 hours after IMP intake Sotagliflozin: Area under the concentration-time curve from 0 to infinity (AUC) for reference, p1, p2, and p3 formulations
Assessment of PK Parameter: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast) From 0 to 144 hours after IMP intake Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration for reference, p1, p2, and p3 formulations
- Secondary Outcome Measures
Name Time Method Assessment of PK Parameter: Tlast From 0 to 144 hours after IMP intake Sotagliflozin 3-O-glucuronide: Time to reach AUClast
Assessment of PK Parameter: Terminal elimination half-life (t1/2) From 0 to 144 hours after IMP intake Sotagliflozin: Terminal elimination half-life (t1/2)
Assessment of PK Parameter: Cmax From 0 to 144 hours after IMP intake Sotagliflozin 3-O-glucuronide: Cmax
Assessment of PK Parameter: AUClast From 0 to 144 hours after IMP intake Sotagliflozin 3-O-glucuronide: AUClast
Assessment of PK Parameter: Tmax From 0 to 144 hours after IMP intake Sotagliflozin 3-O-glucuronide: Tmax
Assessment of PK Parameter: Time to reach AUClast (Tlast) From 0 to 144 hours after IMP intake Sotagliflozin: Time to reach AUClast
Assessment of PK Parameter: t1/2 From 0 to 144 hours after IMP intake Sotagliflozin 3-O-glucuronide: t1/2
Assessment of PK Parameter: AUC From 0 to 144 hours after IMP intake Sotagliflozin 3-O-glucuronide: AUC
Adverse Events Up to 75 days Number of patients with treatment emergent adverse events (serious and non-serious)
Trial Locations
- Locations (1)
Investigational Site Number 276001
🇩🇪Neuss, Germany