Clinical trial NCT01195324: A Drug Interaction Study of Warfarin and Canagliflozin in Healthy Adult Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Canagliflozin (JNJ-28431754)
Warfarin
Pharmacokinetic
Pharmacodynamic
Prothrombin time (PT)
International normalized ratio (INR)
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2010-09-06
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

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 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

Primary outcomes:
measure: Plasma concentrations of canagliflozin
timeFrame: At protocol-specified times during Treatment A on Days 1 through 12.
measure: Plasma concentrations of warfarin
timeFrame: At protocol specified times during Treatment A on Days 6 through 13
measure: Plasma concentrations of warfarin
timeFrame: At protocol specified times during Treatment B on Days 1 through 8
measure: Measurement of Prothrombin time (PT) to assess the international normalized ratio (INR)
timeFrame: At protocol-specified times during Treatment A on Days 6 through 13
measure: Measurement of PT to assess the INR
timeFrame: At protocol-specified time points during Treatment B on Days 1 through 8
Secondary outcomes:
measure: The number and type of adverse events reported
timeFrame: Day 1 of Treatment A through 10 days after Day 8 of Treatment B
measure: The number and type of adverse events reported
timeFrame: Day 1 of Treatment B through 10 days after Day 13 of Treatment A
Other outcomes:
Locations:
city: Merksem
country: Belgium
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Devineni D, Manitpisitkul P, Vaccaro N, Bernard A, Skee D, Mamidi RN, Tian H, Weiner S, Stieltjes H, Sha S, Rothenberg P. Effect of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on the pharmacokinetics of oral contraceptives, warfarin, and digoxin in healthy participants. Int J Clin Pharmacol Ther. 2015 Jan;53(1):41-53. doi: 10.5414/CP202157.