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

Phase 1CompletedNCT01195324

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.14 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Canagliflozin/WarfarinDRUG

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

Canagliflozin/WarfarinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Merksem, Belgium

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 A on Days 6 through 13

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

Time frame: Day 1 of Treatment A through 10 days after Day 8 of Treatment B

The number and type of adverse events reported

Time frame: Day 1 of Treatment B through 10 days after Day 13 of Treatment A

Data from ClinicalTrials.gov

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