A Drug Interaction Study of Warfarin and Canagliflozin in Healthy Adult Volunteers

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Canagliflozin/Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01195324

CR017440

Details and patient eligibility

About

The purpose of the study is to assess the effect of multiple oral doses of canagliflozin on a single oral dose of warfarin.

Full description

This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of canagliflozin (JNJ-28431754) and warfarin in healthy adult volunteers. Canagliflozin is a drug currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus and warfarin is an approved anticoagulant (ie, a drug that stops blood from clotting). After an overnight fast (without eating food) of at least 10 hours, volunteers will receive Sequence 1 (canagliflozin 300 mg, orally, once daily on Days 1-12 with a single, oral 30 mg dose of warfarin on Day 6 [Treatment A] followed 14 days later by a single, oral 30 mg dose of warfarin on Day 1 [Treatment B]) OR Sequence 2 (Treatment B followed 14 days later by Treatment A).

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/m

Exclusion criteria

• Any blood coagulation disorder determined to be clinically relevant by the Investigator
• Medications known to affect coagulation taken within 7 to 14 days of study entry

Trial design

14 participants in 2 patient groups

001

Experimental group

Description:

Canagliflozin/Warfarin Treatment A: Tablets oral canagliflozin 300 mg once daily for 12 days and canagliflozin 300 mg + warfarin 30 mg single dose on Day 6 followed 14 days later by Treatment B: Tablets oral warfarin 30 mg single dose on Day 1

Treatment:

Drug: Canagliflozin/Warfarin

Drug: Canagliflozin/Warfarin

002

Experimental group

Description:

Canagliflozin/Warfarin Treatment B: Tablets oral warfarin 30 mg single dose on Day 1 followed 14 days later by Treatment A: Tablets oral canagliflozin 300 mg once daily for 12 days and canagliflozin 300 mg + warfarin 30 mg single dose on Day 6

Treatment:

Drug: Canagliflozin/Warfarin

Drug: Canagliflozin/Warfarin