A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide

Part of paid clinical trials in Dallas, Texas.

Sponsor
Sanofi
Study ID
NCT03387657
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Sotagliflozin (SAR439954) — DRUG
    Pharmaceutical form: Tablet Route of administration: Oral
  • Hydrochlorothiazide — DRUG
    Pharmaceutical form: Tablet Route of administration: Oral

Study Details

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

Key Dates

Start date
Jan 3, 2018
Status verified
Apr 2022
Primary completion
Mar 2, 2018
Completion
Mar 2, 2018

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sotagliflozin + Hydrochlorothiazide (HCTZ)
    Sotagliflozin to be administered alone in Period 1. HCTZ to be given in Period 2 for 4 days followed immediately by HCTZ and sotagliflozin for 5 days.

Primary Outcome Measure

Assessment of PK parameter: AUCtau [ Time Frame: Period 1, days 2 to 6 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational Site Number 8400001DallasTexas75247-

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