A Phase 1, Single-Center, Open-Label, Two-Period, One-Sequence, Single Dose Study to Determine the Absolute Bioavailability of Sotagliflozin in Healthy Male and Female Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic (PK) parameter: Absolute Bioavailability (F)
Study Overview
Brief Summary
Primary Objective:
To assess the absolute bioavailability of sotagliflozin via administration of an intravenous (IV) microdose of a 14C-sotagliflozin tracer on top of a single oral dose of unlabeled sotagliflozin without charcoal administration
Secondary Objectives:
- To assess the PK of sotagliflozin and its main metabolite sotagliflozin-3-O-glucuronide (M19) after a single oral dose of sotagliflozin and an IV microdose of a 14C-sotagliflozin tracer without charcoal administration
- To assess the safety and tolerability of single doses of sotagliflozin when administered with and without charcoal
Detailed Description
Study duration per participant is up to 54 days including a screening period of up to 28 days, period 1 of 8 days, period 2 of 8 days, a washout period of at least 10 days, and a follow up period of 12-16 days.
The oral drug Sotagliflozin is metabolized by the liver and released in the bile juice into the intestine. Ingestion of charcoal a few hours after the drug administration circumvents the re-uptake of the drug from the intestine back into the blood circulation; instead, Sotagliflozin is eliminated with the feces. By comparison of Sotagliflozin drug administration with and without charcoal, the extent of this so-called enterohepatic circulation can be assessed.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sotagliflozin
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.
Intervention: Sotagliflozin (SAR439954) (Drug)
Sotagliflozin
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.
Intervention: 14C-microtracer (Drug)
Sotagliflozin
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.
Intervention: Charcoal (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic (PK) parameter: Absolute Bioavailability (F)
Time Frame: Baseline to Day 8 of period 1 (without charcoal)
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)
Secondary Outcomes
- Assessment of PK parameter: Area under the curve (AUC) for oral investigational medicinal product (IMP)(Baseline to Day 8 of each period)
- Assessment of PK parameter: Cmax for oral IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: Cmax for IMP metabolite(Baseline to Day 8 of each period)
- Assessment of PK parameter: AUC for IMP metabolite(Baseline to Day 8 of each period)
- Assessment of PK parameter: AUC for IV 14C-IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: AUC for 14C-IMP metabolite(Baseline to Day 8 of each period)
- Assessment of PK parameter: Area under curve versus time (AUClast) for oral IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: AUClast for IMP metabolite(Baseline to Day 8 of each period)
- Assessment of PK parameter: AUClast for IV 14C-IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: AUClast for 14C-IMP metabolite(Baseline to Day 8 of each period)
- Assessment of PK parameter: Cmax for IV 14C-IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: Cmax for 14C-IMP metabolite(Baseline to Day 8 of each period)
- Assessment of PK parameter: tmax for oral IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: tmax for IMP metabolite(Baseline to Day 8 of each period)
- Assessment of PK parameter: tmax for IV 14C-IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: tmax for 14C-IMP metabolite(Baseline to Day 8 of each period)
- Assessment of PK parameter: t1/2z for oral IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: t1/2z for IV 14C-IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: Clearance (CL/F) for oral IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: Clearance (CL/F) for IV 14C-IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: Vz/F for oral IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: Vz/F for IV 14C-IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: Vdss/F for oral IMP(Baseline to Day 8 of each period)
- Assessment of PK parameter: Vdss/F for IV 14C-IMP(Baseline to Day 8 of each period)
- Safety: Adverse events(Baseline to Day 8 of each period)