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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01195324
First received: September 2, 2010
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Canagliflozin/Warfarin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Plasma concentrations of canagliflozin [ Time Frame: At protocol-specified times during Treatment A on Days 1 through 12. ] [ Designated as safety issue: No ]
  • Plasma concentrations of warfarin [ Time Frame: At protocol specified times during Treatment A on Days 6 through 13 ] [ Designated as safety issue: No ]
  • Plasma concentrations of warfarin [ Time Frame: At protocol specified times during Treatment B on Days 1 through 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Measurement of PT to assess the INR [ Time Frame: At protocol-specified time points during Treatment B on Days 1 through 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number and type of adverse events reported [ Time Frame: Day 1 of Treatment A through 10 days after Day 8 of Treatment B ] [ Designated as safety issue: No ]
  • The number and type of adverse events reported [ Time Frame: Day 1 of Treatment B through 10 days after Day 13 of Treatment A ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: September 2010
Study Completion Date: December 2010
Arms Assigned Interventions
Experimental: 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
Drug: 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
Experimental: 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
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195324

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Director, Clin Pharm Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01195324     History of Changes
Other Study ID Numbers: CR017440
Study First Received: September 2, 2010
Last Updated: March 19, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Canagliflozin (JNJ-28431754)
Warfarin
Pharmacokinetic
Pharmacodynamic
Prothrombin time (PT)
International normalized ratio (INR)

Additional relevant MeSH terms:
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014