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Clinical Trial Details

Trial ID: L3154
Source ID: NCT03387657
Associated Drug: Sotagliflozin (Sar439954)
Title: A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sotagliflozin (SAR439954)|DRUG: Hydrochlorothiazide
Outcome Measures: Primary: Assessment of PK parameter: AUCtau, Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau), Period 1, days 2 to 6|Assessment of PK parameter: AUCtau, Sotagliflozin with HCTZ: AUCtau, Period 2, days 6 to 10 | Secondary: Assessment of PK parameter: AUCtau, HCTZ without sotagliflozin: AUCtau, Period 2, days 4 to 5|Assessment of PK parameter: AUCtau, HCTZ with sotagliflozin: AUCtau, Period 2, days 9 to 10|Assessment of PK parameter: AUCtau, Sotagliflozin-3-O-glucuronide without HCTZ: AUCtau, Period 1, days 2 to 6|Assessment of PK parameter: AUCtau, Sotagliflozin-3-O-glucuronide with HCTZ: AUCtau, Period 2, days 6 to 10|Assessment of PK parameter: Cmax, HCTZ without sotagliflozin: Maximum plasma concentration (Cmax), Period 2, days 4 to 5|Assessment of PK parameter: Cmax, HCTZ with sotagliflozin: Cmax, Period 2, days 9 to 10|Assessment of PK parameter: Cmax, Sotagliflozin-3-O-glucuronide without HCTZ: Cmax, Period 1, days 2 to 6|Assessment of PK parameter: Cmax, Sotagliflozin-3-O-glucuronide with HCTZ: Cmax, Period 2, days 6 to 10|Assessment of PK parameter: tmax, HCTZ without sotagliflozin: Time to reach Cmax (tmax), Period 2, days 4 to 5|Assessment of PK parameter: tmax, HCTZ with sotagliflozin: tmax, Period 2, days 9 to 10|Assessment of PK parameter: tmax, Sotagliflozin-3-O-glucuronide without HCTZ: tmax, Period 1, days 2 to 6|Assessment of PK parameter: tmax, Sotagliflozin-3-O-glucuronide with HCTZ: tmax, Period 2, days 6 to 10|Assessment of PK parameter: Cmax, Sotagliflozin without HCTZ: Cmax, Period 1, days 2 to 6|Assessment of PK parameter: Cmax, Sotagliflozin with HCTZ: Cmax, Period 2, days 6 to 10|Assessment of PK parameter: tmax, Sotagliflozin without HCTZ: tmax, Period 1, days 2 to 6|Assessment of PK parameter: tmax, Sotagliflozin with HCTZ: tmax, Period 2, days 6 to 10
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-01-03
Completion Date: 2018-03-02
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 8400001, Dallas, Texas, 75247, United States
URL: https://clinicaltrials.gov/show/NCT03387657