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

September 2, 2010
May 7, 2014
September 2010
December 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01195324 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Drug Interaction Study of Warfarin and Canagliflozin in Healthy Adult Volunteers
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

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).

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • 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
  • 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
  • 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
    Intervention: Drug: Canagliflozin/Warfarin
  • 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
    Intervention: Drug: Canagliflozin/Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01195324
CR017440
Not Provided
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP