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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Canagliflozin; Drug: Rifampin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01395927

CR018604

28431754DIA1029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

14 participants in 1 patient group

001

Experimental group

Description:

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.

Treatment:

Drug: Canagliflozin

Drug: Rifampin