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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Canagliflozin/Warfarin

Intervention Type DRUG

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 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

Group Type EXPERIMENTAL

Canagliflozin/Warfarin

Intervention Type DRUG

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

Interventions

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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 Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes