Repeat Dose Tolerance Study of Regadenoson in Healthy Subjects

NCT01918995 ↗

Phase 1 Completed 36 enrolled Astellas Pharma Global Development, Inc.

RandomizedParallel-groupQuadruple-blind

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.

Timeline

Start: 2013-05
Primary completion: 2013-08
Completion: 2013-08

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Regadenoson	Diagnostic / imaging agent	100 ug	Intravenous
Subject	Regadenoson	Diagnostic / imaging agent	200 ug	Intravenous
Subject	Regadenoson	Diagnostic / imaging agent	400 ug	Intravenous

Indications

No indication recorded.