A Study to Evaluate the Effect of IV ACHN-490 Injection on the QT/QTc Interval in Healthy Volunteers

Phase 1 Completed 64 enrolled Achaogen, Inc. Department of Health and Human Services · collab

RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to determine if the study drug, ACHN-490 Injection, affects the QT interval in normal volunteers. The hypothesis is that the drug will not cause an increase in the QT interval.

Timeline

Start: 2011-10
Primary completion: —
Completion: 2012-03

Outcome

Met primary endpoint

paper No QT prolongation effect for plazomicin was concluded PMID 30650259 ↗

paper the highest upper limit was 5.6 milliseconds. PMID 30650259 ↗

Publications

Gall J, Choi T, Riddle V, Van Wart S, Gibbons JA, Seroogy J. A Phase 1 Study of Intravenous Plazomicin in Healthy Adults to Assess Potential Effects on the QT/QTc Interval, Safety, and Pharmacokinetics. Clin Pharmacol Drug Dev. 2019 Nov;8(8):1032-1041. doi: 10.1002/cpdd.653. Epub 2019 Jan 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Moxifloxacin	Small molecule	400 mg	Oral
Subject	plazomicin	Small molecule	15 mg/kg	Intravenous
Subject	plazomicin	Small molecule	20 mg/kg	Intravenous

Indications

No indication recorded.