A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02000700
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin 100 mg — DRUG
    One 100-mg tablet of canagliflozin orally administered daily for 14 days.
  • Canagliflozin 50 mg — DRUG
    One 50-mg tablet of canagliflozin orally administered daily for 14 days.
  • Canagliflozin 300 mg — DRUG
    One 300-mg tablet of canagliflozin orally administered daily for 14 days.
  • Placebo — DRUG
    One matching placebo tablet orally administered at baseline phase.

Study Details

The purpose of this study is to evaluate the pharmacokinetics (blood levels) and pharmacodynamics (the action or effects a drug has on the body) of canagliflozin in children and adolescents with type 2 diabetes mellitus aged 10 to 17 years (inclusive). Other purposes are to investigate safety and assess the ease of swallowing the tablets.

Key Dates

Start date
Mar 31, 2014
Status verified
Feb 2017
Primary completion
Apr 30, 2016
Completion
Apr 30, 2016

Study Design

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

Arms

  • Experimental: Canagliflozin (Dose Group 1)
    Participants will receive 100 mg (as 1 x 100-mg tablet) of canagliflozin daily for 14 days.
  • Experimental: Canagliflozin (Dose Group 2)
    Participants will be enrolled into Dose Group 2 to receive either 50 mg (as 1 x 50-mg tablet) or 300 mg (as 1 x 300-mg tablet) of canagliflozin daily for 14 days.

Primary Outcome Measure

Plasma concentrations of canagliflozin following multiple oral doses of canagliflozin [ Time Frame: From Days 14 to 17 ]

Locations (13)

FacilityCityStateZIPSite coordinators
-Little RockArkansas--
-Los AngelesCalifornia--
-AuroraColorado--
-New HavenConnecticut--
-JacksonvilleFlorida--
-IndianapolisIndiana--
-LenexaKansas--
-BaltimoreMaryland--
-Kansas CityMissouri--
-ToledoOhio--
-PittsburghPennsylvania--
-HoustonTexas--
-Salt Lake CityUtah--

Find similar trials in Little Rock, AR

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss

Related Studies