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

Johnson & Johnson (J&J) logo

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: Rifampin
Drug: Canagliflozin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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