A Drug Interaction Study of Warfarin and Canagliflozin in Healthy Adult Volunteers
- Conditions
- Healthy
- Interventions
- Drug: Canagliflozin/Warfarin
- Registration Number
- NCT01195324
- Brief Summary
The purpose of the study is to assess the effect of multiple oral doses of canagliflozin on a single oral dose of warfarin.
- Detailed 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Healthy volunteers with a body mass index between 18 and 30 kg/m
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 001 Canagliflozin/Warfarin 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 1 002 Canagliflozin/Warfarin 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
- Primary Outcome Measures
Name Time Method Measurement of PT to assess the INR At protocol-specified time points during Treatment B on Days 1 through 8 Plasma concentrations of canagliflozin At protocol-specified times during Treatment A on Days 1 through 12. Plasma concentrations of warfarin At protocol specified times during Treatment B on Days 1 through 8 Measurement of Prothrombin time (PT) to assess the international normalized ratio (INR) At protocol-specified times during Treatment A on Days 6 through 13
- Secondary Outcome Measures
Name Time Method The number and type of adverse events reported Day 1 of Treatment B through 10 days after Day 13 of Treatment A