Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects
NCT ID: NCT03909451
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2019-04-28
2019-08-19
Brief Summary
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To assess the safety and tolerability of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.
Secondary Objectives:
* To assess the pharmacokinetic (PK) parameters of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.
* To assess the pharmacodynamics (PD) parameters of absolute urinary glucose excretion after a multiple oral dose administration in Chinese healthy subjects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Dose 1
Sotagliflozin dose 1, once daily for 8 days
Sotagliflozin (SAR439954)
Pharmaceutical form: tablet
Route of administration: oral
Dose 2
Sotagliflozin dose 2, once daily for 8 days
Sotagliflozin (SAR439954)
Pharmaceutical form: tablet
Route of administration: oral
Placebo
Placebo, once daily for 8 days
Placebo
Pharmaceutical form: tablet
Route of administration: oral
Interventions
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Sotagliflozin (SAR439954)
Pharmaceutical form: tablet
Route of administration: oral
Placebo
Pharmaceutical form: tablet
Route of administration: oral
Eligibility Criteria
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Inclusion Criteria
* Body weight between 50.0 and 95.0 kg, inclusive, for male or female subjects; body mass index between 18.5 and 27.9 kg/m2, inclusive.
* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination), vital signs, electrocardiogram, and clinical laboratory parameters.
Exclusion Criteria
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 1560001
Beijing, , China
Countries
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Other Identifiers
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U1111-1199-6171
Identifier Type: OTHER
Identifier Source: secondary_id
TDR15349
Identifier Type: -
Identifier Source: org_study_id
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