Trials / Completed
CompletedNCT01918995
Repeat Dose Tolerance Study of Regadenoson in Healthy Subjects
A Phase 1, Randomized, Double-blind, Dose Escalation, Parallel Group, Placebo-controlled, Repeat Dose Tolerance Study of Regadenoson in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Astellas Pharma Global Development, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Regadenoson | Intravenous (IV) |
| DRUG | Placebo | Intravenous (IV) |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2013-08-01
- Completion
- 2013-08-01
- First posted
- 2013-08-08
- Last updated
- 2013-08-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01918995. Inclusion in this directory is not an endorsement.