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

NCT02000700 ↗

Phase 1 Completed 17 enrolled Janssen Research & Development, LLC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2014-03
Primary completion: 2016-04
Completion: 2016-04

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	50 mg	Oral
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	100 mg	Oral
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	300 mg	Oral

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

Summary

Timeline

Drugs

Indications