A Study to Evaluate the Effects of Rifampin on Single-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rifampin; Drug: Canagliflozin

• Registration Number: NCT01395927
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

The purpose of this study is to evaluate blood levels of canagliflozin in healthy volunteers before and after the administration of multiple-doses of rifampin.

Detailed Description

This is an open-label (volunteer and study staff will know the identity of study drugs assigned) study of canagliflozin and rifampin taken in a sequential order by healthy volunteers for up to 12 days. Healthy volunteers will take orally (by mouth) one 300 mg canagliflozin tablet and/or two 300 mg rifampin capsules daily in sequential order as follows: on Day 1 volunteers will take one 300-mg canagliflozin tablet, on Days 4 to 9 volunteers will take two 300-mg rifampin capsules once daily, on Day 10 volunteers will take one 300-mg canagliflozin tablet + two 300-mg rifampin capsules, and on Days 11 and 12 volunteers will take two 300-mg rifamplin capsules once daily.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-18
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-03
• Last Update Posted: 2013-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive)

Exclusion Criteria

• History of or current medical illness deemed clinically significant by the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
001	Canagliflozin	Canagliflozin Type=1 unit=mg number=300 form=tablet. Single dose of one 300-mg tablet on Day 1 and Day 10,Rifampin Type=2 unit=mg number=300 Form=capsule route=oral use. Two 300-mg capsules once daily on days Days 4 through 12.
001	Rifampin	Canagliflozin Type=1 unit=mg number=300 form=tablet. Single dose of one 300-mg tablet on Day 1 and Day 10,Rifampin Type=2 unit=mg number=300 Form=capsule route=oral use. Two 300-mg capsules once daily on days Days 4 through 12.

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of canagliflozin	Day 1 up to Day 13

Secondary Outcome Measures

Name	Time	Method
Adverse events reported	For approximately 13 days
Plasma concentrations of Rifampin	Day 9 up to Day 13