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This study is to determine the safety, tolerability, and pharmacokinetics of two or three repeat intravenous (IV) bolus doses of regadenoson administered 10 minutes apart in healthy supine subjects.
All subjects will receive up to 3 doses of study drug on day 1 after fasting from all food and drink (except water) for at least 8 hours. Subjects will remain in the clinic for 2 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regadenoson low dose | Experimental | Administered over approximately 10 seconds followed by 2 repeat low doses at 10 minute intervals |
|
| Regadenoson medium dose | Experimental | Administered over approximately 10 seconds followed by 2 repeat medium doses at 10 minute intervals |
|
| Regadenoson high dose | Experimental | Administered over approximately 10 seconds followed by 1 repeat high dose at 10 minute intervals |
|
| Placebo | Placebo Comparator | Administered over approximately 10 seconds followed by 1 or 2 repeat doses at 10 minute intervals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regadenoson | Drug | Intravenous (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by vital signs | Pre-dose and up to 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by electrocardiogram (ECG), laboratory evaluations, and adverse events | Up to 72 hours after last dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Early Phase Unit | Baltimore | Maryland | 21225 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26607361 | Derived | Townsend R, Desai A, Rammelsberg D, Kowalski D, Simmons N, Kitt TM. Safety and tolerability of intravenous regadenoson in healthy subjects: A randomized, repeat-dose, placebo-controlled study. J Nucl Cardiol. 2017 Feb;24(1):57-65. doi: 10.1007/s12350-015-0327-9. Epub 2015 Nov 25. |
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| ID | Term |
|---|---|
| C430916 | regadenoson |
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| Placebo | Drug | Intravenous (IV) |
|