Genetics of Response to Canagliflozin

Sponsor
University of Maryland, Baltimore
Study ID
NCT02891954
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin — DRUG
    Healthy volunteers will receive canagliflozin (300 mg per day) in the morning for five days.

Study Details

Five daily doses of canagliflozin (300 mg) will be administered to healthy volunteers. Pharmacodynamic responses to canagliflozin will be assessed both at 2 days and 6 days after administration of the first dose of canagliflozin. A genome-wide association study (GWAS) will be conducted to search for genetic variants that are associated with each of the pharmacodynamic responses to canagliflozin.

Key Dates

Start date
Sep 30, 2016
Status verified
Dec 2025
Primary completion
Sep 25, 2023
Completion
Dec 25, 2026

Study Design

Enrollment
700 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Single arm
    Healthy volunteers will receive canagliflozin to assess pharmacodynamic responses to drug.

Primary Outcome Measure

Urinary glucose excretion (during the time interval 24-48 hours after first administration of canagliflozin) [ Time Frame: 24-48 hours ]

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