Primary Objective: To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A activities using a CYP probe cocktail of metoprolol and midazolam. Secondary Objective: To assess the clinical and laboratory safety of sotagliflozin coadministered with the cocktail probes as compared to that of cocktail probes alone.
The total study duration per subject is up to 58 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: HCl syrup Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Investigational Site Number 840001
Knoxville, Tennessee, United States
Assessment of midazolam pharmacokinetic (PK) parameter: Area under the curve (AUC)
Time frame: Day 1 to Day 2 of Treatment A Period
Assessment of midazolam PK parameter: AUC
Time frame: Day 11 to Day 12 of Treatment B Period
Assessment of metoprolol PK parameter: AUC
Time frame: Day 1 to Day 3 of Treatment A Period
Assessment of metoprolol PK parameter: AUC
Time frame: Day 11 to Day 13 of Treatment B Period
Assessment of PK parameter: maximum plasma concentration (Cmax)
Time frame: Day 1 to Day 2 of Treatment A Period (midazolam)
Assessment of PK parameter: Cmax
Time frame: Day 11 to Day 12 of Treatment B Period (midazolam)
Assessment of PK parameter: Cmax
Time frame: Day 1 to Day 3 of Treatment A Period (metoprolol)
Assessment of PK parameter: Cmax
Time frame: Day 11 to Day 13 of Treatment B Period (metoprolol)
Assessment of PK parameter: time to reach Cmax (Tmax)
Time frame: Day 1 to Day 2 of Treatment A Period (midazolam)
Assessment of PK parameter: Tmax
Time frame: Day 11 to Day 12 of Treatment B Period (midazolam)
Assessment of PK parameter: Tmax
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Time frame: Day 1 to Day 3 of Treatment A Period (metoprolol)
Assessment of PK parameter: Tmax
Time frame: Day 11 to Day 13 of Treatment B Period (metoprolol)
Assessment of PK parameter: terminal-half life (t1/2z)
Time frame: Day 1 to Day 2 of Treatment A Period (midazolam)
Assessment of PK parameter: t1/2z
Time frame: Day 11 to Day 12 of Treatment B Period (midazolam)
Assessment of PK parameter: t1/2z
Time frame: Day 1 to Day 3 of Treatment A Period (metoprolol)
Assessment of PK parameter: t1/2z
Time frame: Day 11 to Day 13 of Treatment B Period (metoprolol)