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

• Plasma concentrations of canagliflozin [ Time Frame: At protocol-specified times during Treatment A on Days 1 through 12. ] [ Designated as safety issue: No ]
• Plasma concentrations of warfarin [ Time Frame: At protocol specified times during Treatment A on Days 6 through 13 ] [ Designated as safety issue: No ]
• Plasma concentrations of warfarin [ Time Frame: At protocol specified times during Treatment B on Days 1 through 8 ] [ Designated as safety issue: No ]
• Measurement of Prothrombin time (PT) to assess the international normalized ratio (INR) [ Time Frame: At protocol-specified times during Treatment A on Days 6 through 13 ] [ Designated as safety issue: No ]
• Measurement of PT to assess the INR [ Time Frame: At protocol-specified time points during Treatment B on Days 1 through 8 ] [ Designated as safety issue: No ]

• The number and type of adverse events reported [ Time Frame: Day 1 of Treatment A through 10 days after Day 8 of Treatment B ] [ Designated as safety issue: No ]
• The number and type of adverse events reported [ Time Frame: Day 1 of Treatment B through 10 days after Day 13 of Treatment A ] [ Designated as safety issue: No ]

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).

• Drug: 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
• Drug: 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

• Experimental: 001
  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
  Intervention: Drug: Canagliflozin/Warfarin
• Experimental: 002
  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
  Intervention: Drug: Canagliflozin/Warfarin

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