Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5833
Source ID: NCT03802487
Associated Drug: Sotagliflozin (Sar439954)
Title: Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Healthy Subjects
Interventions: DRUG: Sotagliflozin (SAR439954)|DRUG: 14C-microtracer|DRUG: Charcoal
Outcome Measures: Primary: Pharmacokinetic (PK) parameter: Absolute Bioavailability (F), 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), Baseline to Day 8 of period 1 (without charcoal) | Secondary: Assessment of PK parameter: Area under the curve (AUC) for oral investigational medicinal product (IMP), Area under the plasma concentration versus time curve extrapolated to infinity for oral IMP, Baseline to Day 8 of each period|Assessment of PK parameter: AUC for IMP metabolite, Area under the plasma concentration versus time curve extrapolated to infinity for IMP metabolite, Baseline to Day 8 of each period|Assessment of PK parameter: AUC for IV 14C-IMP, Area under the plasma concentration versus time curve extrapolated to infinity for IV 14C-IMP, Baseline to Day 8 of each period|Assessment of PK parameter: AUC for 14C-IMP metabolite, Area under the plasma concentration versus time curve extrapolated to infinity for 14C-IMP metabolite, Baseline to Day 8 of each period|Assessment of PK parameter: Area under curve versus time (AUClast) for oral IMP, Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast for oral IMP, Baseline to Day 8 of each period|Assessment of PK parameter: AUClast for IMP metabolite, Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast for IMP metabolite, Baseline to Day 8 of each period|Assessment of PK parameter: AUClast for IV 14C-IMP, Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast for IV 14C-IMP, Baseline to Day 8 of each period|Assessment of PK parameter: AUClast for 14C-IMP metabolite, Area under the plasma concentration versus time curve, Baseline to Day 8 of each period|Assessment of PK parameter: Cmax for oral IMP, Maximum plasma concentration observed for oral IMP, Baseline to Day 8 of each period|Assessment of PK parameter: Cmax for IMP metabolite, Maximum plasma concentration observed for IMP metabolite, Baseline to Day 8 of each period|Assessment of PK parameter: Cmax for IV 14C-IMP, Maximum plasma concentration observed for IV 14C-IMP, Baseline to Day 8 of each period|Assessment of PK parameter: Cmax for 14C-IMP metabolite, Maximum plasma concentration observed for 14C-IMP metabolite, Baseline to Day 8 of each period|Assessment of PK parameter: tmax for oral IMP, Time to reach Cmax for oral IMP, Baseline to Day 8 of each period|Assessment of PK parameter: tmax for IMP metabolite, Time to reach Cmax for IMP metabolite, Baseline to Day 8 of each period|Assessment of PK parameter: tmax for IV 14C-IMP, Time to reach Cmax for IV 14C-IMP, Baseline to Day 8 of each period|Assessment of PK parameter: tmax for 14C-IMP metabolite, Time to reach Cmax for 14C-IMP metabolite, Baseline to Day 8 of each period|Assessment of PK parameter: t1/2z for oral IMP, Terminal half-life (t1/2z) associated with the terminal slope for oral IMP, Baseline to Day 8 of each period|Assessment of PK parameter: t1/2z for IV 14C-IMP, Terminal half-life (t1/2z) associated with the terminal slope for IV 14C-IMP, Baseline to Day 8 of each period|Assessment of PK parameter: Clearance (CL/F) for oral IMP, Apparent total body clearance for oral IMP, Baseline to Day 8 of each period|Assessment of PK parameter: Clearance (CL/F) for IV 14C-IMP, Apparent total body clearance for IV 14C-IMP, Baseline to Day 8 of each period|Assessment of PK parameter: Vz/F for oral IMP, Apparent volume of distribution for oral IMP, Baseline to Day 8 of each period|Assessment of PK parameter: Vz/F for IV 14C-IMP, Apparent volume of distribution for IV 14C-IMP, Baseline to Day 8 of each period|Assessment of PK parameter: Vdss/F for oral IMP, Apparent volume of distribution at the steady state for oral IMP, Baseline to Day 8 of each period|Assessment of PK parameter: Vdss/F for IV 14C-IMP, Apparent volume of distribution at the steady state for IV 14C-IMP, Baseline to Day 8 of each period|Safety: Adverse events, Number of subjects with adverse events including serious, non-serious, and treatment emergent adverse events, Baseline to Day 8 of each period
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 6
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-01-14
Completion Date: 2019-03-28
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational site number 8260001, Nottingham, NG11 6JS, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03802487