A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
Sanofi
Study ID
NCT02940379
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
  • midazolam — DRUG
    Pharmaceutical form: HCl syrup Route of administration: oral
  • metoprolol — DRUG
    Pharmaceutical form: tablet Route of administration: oral

Study Details

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.

Key Dates

Start date
Oct 31, 2016
Status verified
Apr 2022
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 1 of Sotagliflozin plus cocktail) after 3 days
  • Experimental: Cohort 2
    Participants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 2 of Sotagliflozin plus cocktail) after 3 days

Primary Outcome Measure

Assessment of midazolam pharmacokinetic (PK) parameter: Area under the curve (AUC) [ Time Frame: Day 1 to Day 2 of Treatment A Period ]

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational Site Number 840001KnoxvilleTennessee37920-

Find similar trials in Knoxville, TN

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Investigational· Knoxville, TN

Related Studies