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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01195324

Enrollment

Registered

2010-09-06

Start date

2010-09-30

Completion date

2010-12-31

Last updated

2014-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Canagliflozin (JNJ-28431754), Warfarin, Pharmacokinetic, Pharmacodynamic, Prothrombin time (PT), International normalized ratio (INR)

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).

Interventions

DRUGCanagliflozin/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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
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 A on Days 6 through 13
Measurement of Prothrombin time (PT) to assess the international normalized ratio (INR)	At protocol-specified times during Treatment A on Days 6 through 13
Measurement of PT to assess the INR	At protocol-specified time points during Treatment B on Days 1 through 8

Secondary

Measure	Time frame
The number and type of adverse events reported	Day 1 of Treatment A through 10 days after Day 8 of Treatment B

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026