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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195324
• Other study ID #: CR017440
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2010
• Last updated: May 7, 2014
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: May 2014
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of canagliflozin		At protocol-specified times during Treatment A on Days 1 through 12.	No
Primary	Plasma concentrations of warfarin		At protocol specified times during Treatment A on Days 6 through 13	No
Primary	Plasma concentrations of warfarin		At protocol specified times during Treatment B on Days 1 through 8	No
Primary	Measurement of Prothrombin time (PT) to assess the international normalized ratio (INR)		At protocol-specified times during Treatment A on Days 6 through 13	No
Primary	Measurement of PT to assess the INR		At protocol-specified time points during Treatment B on Days 1 through 8	No
Secondary	The number and type of adverse events reported		Day 1 of Treatment A through 10 days after Day 8 of Treatment B	No
Secondary	The number and type of adverse events reported		Day 1 of Treatment B through 10 days after Day 13 of Treatment A	No