A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects


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Verified May 2017 by Sanofi

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT03174548

First received: May 31, 2017

Last updated: June 1, 2017

Last verified: May 2017

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.

Diabetes Mellitus Drug: Sotagliflozin (SAR439954) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
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 Outcome Measures:

  • 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 ]

Secondary Outcome Measures:

  • 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 ]

Estimated Enrollment: 15
Anticipated Study Start Date: June 11, 2017
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Experimental: Fed Tablet period (Test, T)

Sotagliflozin oral in fed conditions

Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral

Experimental: Fasted Tablet period (Reference, R)

Sotagliflozin oral in fasting conditions

Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral

Experimental: Oral Solution period (S)

Sotagliflozin oral solution in fasting conditions

Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: solution

Route of administration: oral

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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria :

  • 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.

Exclusion criteria:

  • 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.
  • 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03174548

Contact: Email recommended (toll free for US & Canada) Trial Transparency Team 800-633-1610 ext 1 then # Contact-US@sanofi.com

Sanofi

Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03174548     History of Changes
Other Study ID Numbers: PKM15047
2016-004650-15 ( EudraCT Number )
U1111-1189-5094 ( Other Identifier: UTN )
Study First Received: May 31, 2017
Last Updated: June 1, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on June 02, 2017