This is a single center, open label, single sequence, two-treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of a single dose of warfarin.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
18
Xmg dose administered as a subcutaneous injection
25mg tablet administered orally
Clinical Site
Mount Royal, Quebec, Canada
The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.
To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacokinetics of a single oral dose of warfarin in healthy adult subjects.
Time frame: Each day for days 1-10 and 15-45
The safety of ISIS 681257 by the incidence of treatment-emergent adverse events.
To evaluate the safety and tolerability of multiple doses of ISIS 681257 40 mg subcutaneous injections when coadministered with a single oral dose of warfarin in healthy adult subjects.
Time frame: 45 days
Prothrombin Time will be measured by testing blood samples at each individual time point.
To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (anticoagulant activity) of a single oral dose of warfarin in healthy adult subjects.
Time frame: Each day for days 1-7 and 15-21
International normalized ratio will be measured at each individual time point by comparing prothrombin time to the normal mean prothrombin time.
To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (anticoagulant activity) of a single oral dose of warfarin in healthy adult subjects.
Time frame: Each day for days 1-7 and 15-21
Activated partial thromboplastin time will be measured by testing blood samples at each individual time point.
To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (anticoagulant activity) of a single oral dose of warfarin in healthy adult subjects.
Time frame: Each day for days 1-7 and 15-21
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The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.
To evaluate the effect of a single dose of warfarin on the pharmacokinetics of a single subcutaneous 40 mg injection of ISIS 681257 in healthy adult subjects.
Time frame: Each day for days 1-10 and 15-45