Type 2 Diabetes MellitusPhase 1NCT03802487
Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects
A Phase 1 study testing Sotagliflozin (SAR439954), 14C-microtracer and Charcoal in people with Type 2 Diabetes Mellitus and Healthy Subjects, run by Sanofi at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Healthy Subjects
- What is being tested?
- Sotagliflozin (SAR439954), 14C-microtracer and Charcoal
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2019to 28 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 acceptable if investigator judges the subject to have a high muscle mass.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Normal vital signs, ECG and laboratory parameters.
Who cannot join
- Any history or presence of clinically relevant abnormalities at screening which could interfere with the objectives of the study or the safety of the subject's participation.
- Blood donation (400 mL) within 3 months before inclusion.
- History or presence of drug or alcohol abuse.
- Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study.
- Excessive consumption of beverages containing xanthine bases.
- If female, pregnancy (defined as positive β-Human Chorionic Gonadotropin blood test), breast-feeding.
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- Any medication (including St John's Wort) within 14 days before inclusion with the exception of menopausal hormone replacement therapy; any vaccination within last 28 days; any biologics given within last 4 months.
- Any subject in the exclusion period of a previous study.
- Any subject who cannot be contacted in case of emergency.
- Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies.
- Positive result on urine drug screen.
- Positive alcohol test.
- Participation in a study in which radioisotopes were administered or in which subject was exposed to any radiation other than normal background radiation within the 12 months before the screening visit.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Investigational site number 8260001
Nottingham, NG11 6JS
About this study
Official title: 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
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
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Healthy Subjects
- Being tested
- Sotagliflozin (SAR439954), 14C-microtracer, Charcoal
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sotagliflozin (SAR439954)Drug
Pharmaceutical form: Tablet
Route of administration: Oral
14C-microtracerDrug
Pharmaceutical form: Solution for injection
Route of administration: Intravenous
CharcoalDrug
Pharmaceutical form: Granules for suspension
Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sotagliflozin (SAR439954); Drug: 14C-microtracer; Drug: Charcoal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to Day 8 of period 1 (without charcoal)
Secondary outcomes (25)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to Day 8 of each period
Assessment of PK parameter: AUClast for 14C-IMP metabolite
Area under the plasma concentration versus time curve
Measured: Baseline to Day 8 of each period
Assessment of PK parameter: Cmax for oral IMP
Maximum plasma concentration observed for oral IMP
Measured: Baseline to Day 8 of each period
Assessment of PK parameter: Cmax for IMP metabolite
Maximum plasma concentration observed for IMP metabolite
Measured: Baseline to Day 8 of each period
Assessment of PK parameter: Cmax for IV 14C-IMP
Maximum plasma concentration observed for IV 14C-IMP
Measured: Baseline to Day 8 of each period
Assessment of PK parameter: Cmax for 14C-IMP metabolite
Maximum plasma concentration observed for 14C-IMP metabolite
Measured: Baseline to Day 8 of each period
Assessment of PK parameter: tmax for oral IMP
Time to reach Cmax for oral IMP
Measured: Baseline to Day 8 of each period
Assessment of PK parameter: tmax for IMP metabolite
Time to reach Cmax for IMP metabolite
Measured: Baseline to Day 8 of each period
Assessment of PK parameter: tmax for IV 14C-IMP
Time to reach Cmax for IV 14C-IMP
Measured: Baseline to Day 8 of each period
Assessment of PK parameter: tmax for 14C-IMP metabolite
Time to reach Cmax for 14C-IMP metabolite
Measured: 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
Measured: 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
Measured: Baseline to Day 8 of each period
Assessment of PK parameter: Clearance (CL/F) for oral IMP
Apparent total body clearance for oral IMP
Measured: 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
Measured: Baseline to Day 8 of each period
Assessment of PK parameter: Vz/F for oral IMP
Apparent volume of distribution for oral IMP
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to Day 8 of each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start14 Jan 2019
- Primary completion28 Mar 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802487
- Sponsor's protocol ID
- PKM15402
- Other IDs
- 2017-004937-94, U1111-1200-2077, 2017
- Status last verified
- Apr 2022
- First submitted
- 10 Jan 2019
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03802487
- Acronym / sponsor ID
- PKM15402
- Conditions
- Type 2 Diabetes Mellitus, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sotagliflozin | Experimental | Drug: Sotagliflozin (SAR439954), Drug: 14C-microtracer, Drug: CharcoalOne 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 acceptable if investigator judges the subject to have a high muscle mass.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Normal vital signs, ECG and laboratory parameters.
Key exclusion criteria (14 listed)
- Any history or presence of clinically relevant abnormalities at screening which could interfere with the objectives of the study or the safety of the subject's participation.
- Blood donation (400 mL) within 3 months before inclusion.
- History or presence of drug or alcohol abuse.
- Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study.
- Excessive consumption of beverages containing xanthine bases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sotagliflozin (SAR439954)Pharmaceutical form: Tablet Route of administration: Oral | Drug | Sotagliflozin |
| 14C-microtracerPharmaceutical form: Solution for injection Route of administration: Intravenous | Drug | Sotagliflozin |
| CharcoalPharmaceutical form: Granules for suspension Route of administration: Oral | Drug | Sotagliflozin |
Primary outcome
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)
25 secondary outcomes
Assessment of PK parameter: Area under the curve (AUC) for oral investigational medicinal product (IMP)
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: AUC for IMP metabolite
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: AUC for IV 14C-IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: AUC for 14C-IMP metabolite
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: Area under curve versus time (AUClast) for oral IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: AUClast for IMP metabolite
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: AUClast for IV 14C-IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: AUClast for 14C-IMP metabolite
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: Cmax for oral IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: Cmax for IMP metabolite
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: Cmax for IV 14C-IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: Cmax for 14C-IMP metabolite
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: tmax for oral IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: tmax for IMP metabolite
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: tmax for IV 14C-IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: tmax for 14C-IMP metabolite
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: t1/2z for oral IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: t1/2z for IV 14C-IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: Clearance (CL/F) for oral IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: Clearance (CL/F) for IV 14C-IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: Vz/F for oral IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: Vz/F for IV 14C-IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: Vdss/F for oral IMP
Time frame: Baseline to Day 8 of each period
Assessment of PK parameter: Vdss/F for IV 14C-IMP
Time frame: Baseline to Day 8 of each period
Safety: Adverse events
Time frame: Baseline to Day 8 of each period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sotagliflozin (SAR439954), 14C-microtracer and Charcoal in people with Type 2 Diabetes Mellitus and Healthy Subjects, run by Sanofi at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic (PK) parameter: Absolute Bioavailability (F) (time frame: Baseline to Day 8 of period 1 (without charcoal)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.