Diabetes MellitusPhase 1NCT03174548
A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects
A Phase 1 study testing Sotagliflozin (SAR439954) in people with Diabetes Mellitus, run by Sanofi at 1 site in United Kingdom.
Trial summary
Primary Objective: To evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative to a fasted state in healthy adult male and female subjects. Secondary Objectives: To evaluate the effect of food on the single-dose pharmacokinetics of the main metabolite (sotagliflozin 3-O-glucuronide)… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Sotagliflozin (SAR439954)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2017to 15 Sep 2017
- 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
- Healthy male and female subjects, between 18 and 55 years of age, inclusive, at the time of screening.
- Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female; body mass index between 18.0 and 30.0 kg/m2, inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination), vital signs, ECG, and clinical laboratory parameters.
Who cannot join
- Any history or presence of clinically relevant illness at screening, which could interfere with the objectives of the study or the safety of the subject's participation.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- Blood donation any volume, within 2 months before inclusion.
- Symptomatic postural hypotension.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- History or presence of drug or alcohol abuse.
Show all 10Show fewer
- Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
- If female, pregnancy, breast-feeding.
- Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- 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.
About this study
Official title: A Phase 1, Randomized, Single-center, Open-label, Three-sequence, Three-period, Three-treatment Crossover Study to Evaluate the Effect of Food on the Single-dose Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability of Sotagliflozin Oral Tablet to Oral Solution in Healthy Male and Female Subjects
Primary Objective:
To evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative to a fasted state in healthy adult male and female subjects.
Secondary Objectives:
- To evaluate the effect of food on the single-dose pharmacokinetics of the main metabolite (sotagliflozin 3-O-glucuronide) relative to a fasted state in healthy adult male and female subjects.
- To investigate the relative bioavailability of sotagliflozin tablet to oral solution under fasting conditions
- To evaluate safety and tolerability of single-dose sotagliflozin under fed and fasted conditions in healthy adult male and female subjects.
Read the detailed description
The study duration per subject will be 26 to 83 days and will consist of a screening period of 2-28 days, a treatment period of 6 days each for Periods 1, 2 and 3, a washout between treatment periods of 1-14 days, and follow up visit 10-15 days after the last Investigational Medicinal Product administration in period 3.
- Conditions
- Diabetes Mellitus
- Being tested
- Sotagliflozin (SAR439954)
- Medical subject headings
- Diabetes Mellitus
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
Sotagliflozin (SAR439954)Drug
Pharmaceutical form: solution
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Fed Tablet period (Test, T) | Experimental | Sotagliflozin oral in fed conditions Receives: Drug: Sotagliflozin (SAR439954) |
| Fasted Tablet period (Reference, R) | Experimental | Sotagliflozin oral in fasting conditions Receives: Drug: Sotagliflozin (SAR439954) |
| Oral Solution period (S) | Experimental | Sotagliflozin oral solution in fasting conditions Receives: Drug: Sotagliflozin (SAR439954) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma drug concentration (Cmax) of sotagliflozin
Measured: From 0 to 120 hours after sotagliflozin intake
Area under curve (AUC) of sotagliflozin
Measured: From 0 to 120 hours after sotagliflozin intake
Secondary outcomes (10)
Sotagliflozin (tablet and oral solution):Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)
Measured: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin (tablet and oral solution): Time to reach maximum plasma concentration (tmax)
Measured: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin (tablet and oral solution): Elimination half-life (t1/2z)
Measured: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin-O-glucuronide (tablet and oral solution): Cmax
Measured: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin-O-glucuronide (tablet and oral solution): tmax
Measured: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin-O-glucuronide (tablet and oral solution): t1/2z
Measured: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin-O-glucuronide (tablet and oral solution): Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Measured: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin-O-glucuronide (tablet and oral solution): AUC
Measured: From 0 to 120 hours after sotagliflozin intake
Relative bioavailability (Frel)
Measured: From 0 to 120 hours after sotagliflozin intake
Number (%) of subjects with treatment emergent adverse events
Measured: Over 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start12 Jun 2017
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT03174548
- Sponsor's protocol ID
- PKM15047
- Other IDs
- 2016-004650-15, U1111-1189-5094, 2016
- Status last verified
- Apr 2022
- First submitted
- 31 May 2017
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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, Randomized, Single-center, Open-label, Three-sequence, Three-period, Three-treatment Crossover Study to Evaluate the Effect of Food on the Single-dose Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability of Sotagliflozin Oral Tablet to Oral Solution in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03174548
- Acronym / sponsor ID
- PKM15047
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 2 Jun 2017 (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 evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative to a fasted state in healthy adult male and female subjects.
Secondary Objectives:
- To evaluate the effect of food on the single-dose pharmacokinetics of the main metabolite (sotagliflozin 3-O-glucuronide) relative to a fasted state in healthy adult male and female subjects.
- To investigate the relative bioavailability of sotagliflozin tablet to oral solution under fasting conditions
- To evaluate safety and tolerability of single-dose sotagliflozin under fed and fasted conditions in healthy adult male and female subjects.
Detailed description
The study duration per subject will be 26 to 83 days and will consist of a screening period of 2-28 days, a treatment period of 6 days each for Periods 1, 2 and 3, a washout between treatment periods of 1-14 days, and follow up visit 10-15 days after the last Investigational Medicinal Product administration in period 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fed Tablet period (Test, T) | Experimental | Drug: Sotagliflozin (SAR439954)Sotagliflozin oral in fed conditions |
| Fasted Tablet period (Reference, R) | Experimental | Drug: Sotagliflozin (SAR439954)Sotagliflozin oral in fasting conditions |
| Oral Solution period (S) | Experimental | Drug: Sotagliflozin (SAR439954)Sotagliflozin oral solution in fasting conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female subjects, between 18 and 55 years of age, inclusive, at the time of screening.
- Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female; body mass index between 18.0 and 30.0 kg/m2, inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination), vital signs, ECG, and clinical laboratory parameters.
Key exclusion criteria (10 listed)
- Any history or presence of clinically relevant illness at screening, which could interfere with the objectives of the study or the safety of the subject's participation.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- Blood donation any volume, within 2 months before inclusion.
- Symptomatic postural hypotension.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
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 | Fasted Tablet period (Reference, R), Fed Tablet period (Test, T) |
| Sotagliflozin (SAR439954)Pharmaceutical form: solution Route of administration: oral | Drug | Oral Solution period (S) |
Primary outcome
Maximum plasma drug concentration (Cmax) of sotagliflozin
Time frame: From 0 to 120 hours after sotagliflozin intake
Area under curve (AUC) of sotagliflozin
Time frame: From 0 to 120 hours after sotagliflozin intake
10 secondary outcomes
Sotagliflozin (tablet and oral solution):Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)
Time frame: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin (tablet and oral solution): Time to reach maximum plasma concentration (tmax)
Time frame: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin (tablet and oral solution): Elimination half-life (t1/2z)
Time frame: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin-O-glucuronide (tablet and oral solution): Cmax
Time frame: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin-O-glucuronide (tablet and oral solution): tmax
Time frame: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin-O-glucuronide (tablet and oral solution): t1/2z
Time frame: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin-O-glucuronide (tablet and oral solution): Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Time frame: From 0 to 120 hours after sotagliflozin intake
Sotagliflozin-O-glucuronide (tablet and oral solution): AUC
Time frame: From 0 to 120 hours after sotagliflozin intake
Relative bioavailability (Frel)
Time frame: From 0 to 120 hours after sotagliflozin intake
Number (%) of subjects with treatment emergent adverse events
Time frame: Over 9 weeks
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) in people with Diabetes Mellitus, 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 3 inclusion and 10 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?
Maximum plasma drug concentration (Cmax) of sotagliflozin (time frame: From 0 to 120 hours after sotagliflozin intake). The study lists 2 primary outcomes in all. 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.