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NCT Number: NCT01195324

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

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Merksem, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Canagliflozin/Warfarin

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

Primary outcomes

  1. Plasma concentrations of canagliflozin

    Time frame: At protocol-specified times during Treatment A on Days 1 through 12.

  2. Plasma concentrations of warfarin

    Time frame: At protocol specified times during Treatment A on Days 6 through 13

  3. Plasma concentrations of warfarin

    Time frame: At protocol specified times during Treatment B on Days 1 through 8

  4. 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

  5. Measurement of PT to assess the INR

    Time frame: At protocol-specified time points during Treatment B on Days 1 through 8

Secondary outcomes

  1. The number and type of adverse events reported

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

  2. The number and type of adverse events reported

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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 6, 2010
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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