Primary Objective: To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin. Secondary Objectives: * To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ * To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ * To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide
Duration of the study for each subject will be between 33 to 77 days, including screening up to 28 days, 5 days of treatment Period 1, washout period of 7-21 days, 9 days of treatment Period 2, and follow-up period of 10-14 days after last dose of the Investigational Medicinal Product (IMP) in Period 2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Pharmaceutical form: Tablet Route of administration: Oral
Pharmaceutical form: Tablet Route of administration: Oral
Investigational Site Number 8400001
Dallas, Texas, United States
Assessment of PK parameter: AUCtau
Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: AUCtau
Sotagliflozin with HCTZ: AUCtau
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: AUCtau
HCTZ without sotagliflozin: AUCtau
Time frame: Period 2, days 4 to 5
Assessment of PK parameter: AUCtau
HCTZ with sotagliflozin: AUCtau
Time frame: Period 2, days 9 to 10
Assessment of PK parameter: AUCtau
Sotagliflozin-3-O-glucuronide without HCTZ: AUCtau
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: AUCtau
Sotagliflozin-3-O-glucuronide with HCTZ: AUCtau
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: Cmax
HCTZ without sotagliflozin: Maximum plasma concentration (Cmax)
Time frame: Period 2, days 4 to 5
Assessment of PK parameter: Cmax
HCTZ with sotagliflozin: Cmax
Time frame: Period 2, days 9 to 10
Assessment of PK parameter: Cmax
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Sotagliflozin-3-O-glucuronide without HCTZ: Cmax
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: Cmax
Sotagliflozin-3-O-glucuronide with HCTZ: Cmax
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: tmax
HCTZ without sotagliflozin: Time to reach Cmax (tmax)
Time frame: Period 2, days 4 to 5
Assessment of PK parameter: tmax
HCTZ with sotagliflozin: tmax
Time frame: Period 2, days 9 to 10
Assessment of PK parameter: tmax
Sotagliflozin-3-O-glucuronide without HCTZ: tmax
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: tmax
Sotagliflozin-3-O-glucuronide with HCTZ: tmax
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: Cmax
Sotagliflozin without HCTZ: Cmax
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: Cmax
Sotagliflozin with HCTZ: Cmax
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: tmax
Sotagliflozin without HCTZ: tmax
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: tmax
Sotagliflozin with HCTZ: tmax
Time frame: Period 2, days 6 to 10