Cardiovascular Diseases, Elevated Lipoprotein(a)
Conditions
Brief summary
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.
Interventions
DRUGISIS 681257
Xmg dose administered as a subcutaneous injection
DRUGWarfarin
25mg tablet administered orally
Sponsors
Akcea Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Motivated and available for duration of study and willing to adhere to protocol * Males who are unable to procreate or agree to contraception throughout study * Females who are postmenopausal or surgically sterile * BMI between 18.5 and 30 kg/m2 * Weighing greater than or equal to 50kg * Normal lab results * No known diseases or significant findings on physical exam
Exclusion criteria
* Females of childbearing potential * Reactions/infection at injection site * Hypersensitivity to any drugs or similar drugs to those used in the study * Conditions or disease that may interfere with study drug * Any significant diseases * Known history or familial history of bleeding disorders * Drug dependency or abuse * Illness within 28 days * Previous exposure to other investigational drug within 28 days * Blood donations within 28 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point. | Each day for days 1-10 and 15-45 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The safety of ISIS 681257 by the incidence of treatment-emergent adverse events. | 45 days | 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. |
| Prothrombin Time will be measured by testing blood samples at each individual time point. | Each day for days 1-7 and 15-21 | 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. |
| International normalized ratio will be measured at each individual time point by comparing prothrombin time to the normal mean prothrombin time. | Each day for days 1-7 and 15-21 | 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. |
| Activated partial thromboplastin time will be measured by testing blood samples at each individual time point. | Each day for days 1-7 and 15-21 | 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. |
| The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point. | Each day for days 1-10 and 15-45 | 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. |
Countries
Canada
Outcome results
None listed