A Phase 1 interventional study of ISIS 681257 and Warfarin in Elevated Lipoprotein(a) and Cardiovascular Diseases, sponsored by Akcea Therapeutics. Completed at 1 site in Canada. Open to participants aged 16 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by Akcea Therapeutics · Phase 1, Interventional, and Other
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.
Exclusion Criteria:
Single dose of warfarin administered to obtain pharmacokinetic information.
Drug: Warfarin
ISIS 681257 administered and pharmacokinetic assessments are taken. Then ISIS 681257 is administered with warfarin and additional pharmacokinetic information is obtained.
Drug: ISIS 681257 · Drug: Warfarin
Xmg dose administered as a subcutaneous injection
25mg tablet administered orally
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
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
Plan to share: No
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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Akcea Therapeutics