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Clinical Trial Details

Trial ID: L5173
Source ID: NCT02940379
Associated Drug: Sotagliflozin (Sar439954)
Title: A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: sotagliflozin (SAR439954)|DRUG: midazolam|DRUG: metoprolol
Outcome Measures: Primary: Assessment of midazolam pharmacokinetic (PK) parameter: Area under the curve (AUC), Day 1 to Day 2 of Treatment A Period|Assessment of midazolam PK parameter: AUC, Day 11 to Day 12 of Treatment B Period|Assessment of metoprolol PK parameter: AUC, Day 1 to Day 3 of Treatment A Period|Assessment of metoprolol PK parameter: AUC, Day 11 to Day 13 of Treatment B Period | Secondary: Assessment of PK parameter: maximum plasma concentration (Cmax), Day 1 to Day 2 of Treatment A Period (midazolam)|Assessment of PK parameter: Cmax, Day 11 to Day 12 of Treatment B Period (midazolam)|Assessment of PK parameter: Cmax, Day 1 to Day 3 of Treatment A Period (metoprolol)|Assessment of PK parameter: Cmax, Day 11 to Day 13 of Treatment B Period (metoprolol)|Assessment of PK parameter: time to reach Cmax (Tmax), Day 1 to Day 2 of Treatment A Period (midazolam)|Assessment of PK parameter: Tmax, Day 11 to Day 12 of Treatment B Period (midazolam)|Assessment of PK parameter: Tmax, Day 1 to Day 3 of Treatment A Period (metoprolol)|Assessment of PK parameter: Tmax, Day 11 to Day 13 of Treatment B Period (metoprolol)|Assessment of PK parameter: terminal-half life (t1/2z), Day 1 to Day 2 of Treatment A Period (midazolam)|Assessment of PK parameter: t1/2z, Day 11 to Day 12 of Treatment B Period (midazolam)|Assessment of PK parameter: t1/2z, Day 1 to Day 3 of Treatment A Period (metoprolol)|Assessment of PK parameter: t1/2z, Day 11 to Day 13 of Treatment B Period (metoprolol)
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-10
Completion Date: 2016-12
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 840001, Knoxville, Tennessee, 37920, United States
URL: https://clinicaltrials.gov/show/NCT02940379