A Placebo-controlled Four Way Crossover Study to Asses the Effect of a Single Oral Dose of NKTR-118 on QTc Interval in Healthy Male Subjects

Phase 1 Completed 45 enrolled AstraZeneca

RandomizedCrossoverDouble-blindBasic science

Summary

The purpose of this study is to evaluate the effects on QTc interval in healthy males when administered a single dose of NKTR-118 compared with placebo and moxifloxacin. (QTc is a specific time interval that can be measured in a heart beat by taking Electrocardiogram (ECG))

Timeline

Start: 2011-04
Primary completion: 2011-07
Completion: 2011-07

Outcome

Met primary endpoint

paper all upper limits of the 2-sided 90% CI were <10 msec. PMID 24238792 ↗

paper Naloxegol at 25 and 150 mg was not associated with QT/QTc interval prolongation PMID 24238792 ↗

Publications

Gottfridsson C, Carlson G, Lappalainen J, Sostek M. Evaluation of the effect of Naloxegol on cardiac repolarization: a randomized, placebo- and positive-controlled crossover thorough QT/QTc study in healthy volunteers. Clin Ther. 2013 Dec;35(12):1876-83. doi: 10.1016/j.clinthera.2013.09.019. Epub 2013 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Moxifloxacin	Small molecule	400 mg	—
Subject	Naloxegol	Unknown	25 mg	Oral
Subject	Naloxegol	Unknown	150 mg	Oral