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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 multiple doses of clopidogrel
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel Dosing | Experimental | Multiple doses of Clopidogrel to obtain pharmacokinetic information. |
|
| Clopidogrel in combination with ISIS 681257 | Experimental | Multiple doses of clopidogrel administered with 2 doses of ISIS 681257 at 2 individual timepoints to obtain pharmacokinetic information. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISIS 681257 | Drug | Xmg dose administered as a subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the PK of multiple oral doses of clopidogrel in healthy adult subjects | The plasma concentrations of Clopidogrel and ISIS 681257 will be measured at each individual time point. | 55 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections when co-administered with multiple oral doses of clopidogrel in healthy adult subjects | Safety will be assessed by summarizing the reported adverse events | 55 days |
| Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (antiplatelet activity) of multiple doses of clopidogrel in healthy adult subjects |
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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 |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Clopidogrel | Drug | 75mg tablet administered orally |
|
P2Y12 reaction units (PRUs) will be measured at each individual time point. |
| 55 days |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |