Status:
COMPLETED
Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 ...
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 1...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- 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.
- Exclusion criteria:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
January 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03802487
Start Date
January 14 2019
End Date
March 28 2019
Last Update
April 25 2022
Active Locations (1)
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1
Investigational site number 8260001
Nottingham, United Kingdom, NG11 6JS