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

An Open-Label Drug Interaction Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Administered Alone and in Combination With Multiple-Dose JNJ-28431754 (Canagliflozin) in Healthy Male and Female Subjects

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

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).

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