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Trial record 8 of 15 for:    PKM

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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ClinicalTrials.gov Identifier: NCT03174548
Recruitment Status : Completed
First Posted : June 2, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief 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) 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Sotagliflozin (SAR439954) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Actual Study Start Date : June 12, 2017
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : September 15, 2017

Arm Intervention/treatment
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





Primary Outcome Measures :
  1. Maximum plasma drug concentration (Cmax) of sotagliflozin [ Time Frame: From 0 to 120 hours after sotagliflozin intake ]
  2. Area under curve (AUC) of sotagliflozin [ Time Frame: From 0 to 120 hours after sotagliflozin intake ]

Secondary Outcome Measures :
  1. 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 ]
  2. Sotagliflozin (tablet and oral solution): Time to reach maximum plasma concentration (tmax) [ Time Frame: From 0 to 120 hours after sotagliflozin intake ]
  3. Sotagliflozin (tablet and oral solution): Elimination half-life (t1/2z) [ Time Frame: From 0 to 120 hours after sotagliflozin intake ]
  4. Sotagliflozin-O-glucuronide (tablet and oral solution): Cmax [ Time Frame: From 0 to 120 hours after sotagliflozin intake ]
  5. Sotagliflozin-O-glucuronide (tablet and oral solution): tmax [ Time Frame: From 0 to 120 hours after sotagliflozin intake ]
  6. Sotagliflozin-O-glucuronide (tablet and oral solution): t1/2z [ Time Frame: From 0 to 120 hours after sotagliflozin intake ]
  7. 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 ]
  8. Sotagliflozin-O-glucuronide (tablet and oral solution): AUC [ Time Frame: From 0 to 120 hours after sotagliflozin intake ]
  9. Relative bioavailability (Frel) [ Time Frame: From 0 to 120 hours after sotagliflozin intake ]
  10. Number (%) of subjects with treatment emergent adverse events [ Time Frame: Over 9 weeks ]


Information from the National Library of Medicine

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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174548


Locations
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United Kingdom
Investigational Site Number 826001
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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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 )
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
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

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

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pharmaceutical Solutions
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs