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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01195324
First received: September 2, 2010
Last updated: May 7, 2014
Last verified: May 2014
  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
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
Merksem, Belgium
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: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01195324     History of Changes
Other Study ID Numbers: CR017440
Study First Received: September 2, 2010
Last Updated: May 7, 2014
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 September 30, 2014