A Pharmacokinetic Dose Proportionality Study of Canagliflozin in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Canagliflozin, 50 mg; Drug: Canagliflozin, 300 mg; Drug: Canagliflozin, 100 mg

• Registration Number: NCT01340677
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

The purpose of this study is to evaluate the effect of dose on the pharmacokinetics of canagliflozin in healthy volunteers.

Detailed Description

This is an open-label study where healthy volunteers will know the name and dose of assigned treatment and will be randomly assigned to take a single oral (by mouth) dose of canagliflozin sequentially in each of 3 treament periods where the dose in each treatment period will be different (referred to as a 3-period crossover study) to evaluate the pharmacokinetics (blood levels) of 3 dose levels of canagliflozin. Healthy volunteers will take a single oral tablet of canagliflozin 50 mg (Treatment A), 100 mg (Treatment B), and 300 mg (Treatment C) during the study; a different dose will be taken in each treatment period. Study drug will be taken in the a.m. on Day 1 of Treatment Periods 1, 2, and 3, with a 10- to 14-day washout period between Day 1 of each treatment period. Volunteers will fast (go without food) for at least 10 hours before and up to at least 4 hours after taking study drug.

Study Timeline

• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-22
• Study Start: 2011-05
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-16
• Last Update Posted: 2012-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg

Exclusion Criteria

• History of or current medical illness deemed clinically significant by the Investigator (study physician)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
001	Canagliflozin, 50 mg	Canagliflozin 100 mg Type=1 unit=mg number=100 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 300 mg Type=1 unit=mg number=300 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 50 mg Type=1 unit=mg number=50 form=tablet route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.
001	Canagliflozin, 300 mg	Canagliflozin 100 mg Type=1 unit=mg number=100 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 300 mg Type=1 unit=mg number=300 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 50 mg Type=1 unit=mg number=50 form=tablet route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.
001	Canagliflozin, 100 mg	Canagliflozin 100 mg Type=1 unit=mg number=100 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 300 mg Type=1 unit=mg number=300 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 50 mg Type=1 unit=mg number=50 form=tablet route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of canagliflozin	For up to 12 days (4 days during treatment periods 1, 2, and 3)

Secondary Outcome Measures

Name	Time	Method
Clinical laboratory tests	Up to approximately 42 days
Physical examinations	Up to approximately 42 days
12-lead electrocardiograms (ECGs)	Up to approximately 42 days
Vital signs	Up to approximately 42 days
Adverse events	Up to approximately 42 days (includes up to 14 days between Treatment Periods 1 and 2 and up to 10 days after Day 4 of Treatment Period 3)