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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 14
- Primary Endpoint
- Plasma concentrations of canagliflozin
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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: Canagliflozin/Warfarin (Drug)
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: Canagliflozin/Warfarin (Drug)
Outcomes
Primary Outcomes
Plasma concentrations of canagliflozin
Time Frame: At protocol-specified times during Treatment A on Days 1 through 12.
Plasma concentrations of warfarin
Time Frame: At protocol specified times during Treatment B on Days 1 through 8
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
Measurement of PT to assess the INR
Time Frame: At protocol-specified time points during Treatment B on Days 1 through 8
Secondary Outcomes
- The number and type of adverse events reported(Day 1 of Treatment B through 10 days after Day 13 of Treatment A)