ADASUVE 2-dose Thorough QT/QTc Study

Phase 4 Completed 60 enrolled Alexza Pharmaceuticals, Inc.

RandomizedCrossoverQuadruple-blindOther

Summary

Assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.

Timeline

Start: 2013-05
Primary completion: 2013-07
Completion: 2013-07

Outcome

Met primary endpoint

paper no ΔΔQTcI 95% upper CI exceeded 10 msec; the largest was 6.31 msec 5 minutes post dose 2. PMID 26445139 ↗

Publications

Background Cassella JV, Spyker DA, Yeung PP. A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers. Int J Clin Pharmacol Ther. 2015 Nov;53(11):963-71. doi: 10.5414/CP202457.
Cassella JV, Spyker DA, Yeung PP. A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers. Int J Clin Pharmacol Ther. 2015 Oct 7. doi: 10.5414/CP202457. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Moxifloxacin	Small molecule	400 mg	Oral
Subject	loxapine	Small molecule	10 mg	Inhaled

Indications

No indication recorded.