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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of warfarin | Experimental | Single dose of warfarin administered to obtain pharmacokinetic information. |
|
| Warfarin in combination with ISIS 681257 | Experimental | ISIS 681257 administered and pharmacokinetic assessments are taken. Then ISIS 681257 is administered with warfarin and additional pharmacokinetic information is obtained. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISIS 681257 | Drug | Xmg dose administered as a subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Each day for days 1-10 and 15-45 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 45 days |
| Prothrombin Time will be measured by testing blood samples at each individual time point. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Mount Royal | Quebec | H3P 3H5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37070852 | Derived | Milosavljevic MN, Stefanovic SM, Pejcic AV. Potential Novel RNA-Targeting Agents for Effective Lipoprotein(a) Lowering: A Systematic Assessment of the Evidence From Completed and Ongoing Developmental Clinical Trials. J Cardiovasc Pharmacol. 2023 Jul 1;82(1):1-12. doi: 10.1097/FJC.0000000000001429. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Warfarin | Drug | 25mg tablet administered orally |
|
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. |
| 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. | 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. | 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. | Each day for days 1-10 and 15-45 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |