Fentanyl Sublingual Spray in Opioid Naive Participants

Phase 1 Completed 96 enrolled INSYS Therapeutics Inc

RandomizedParallel-groupOpen-labelBasic science

Summary

The primary objective of this trial is to determine the pharmacokinetic and pharmacodynamic relationship of multiple dose administration of fentanyl sublingual spray in opioid naive participants. The secondary objective is to determine the safety and tolerability of multiple dose administration of fentanyl sublingual spray in opioid naive subjects.

Timeline

Start: 2016-01
Primary completion: 2016-03
Completion: 2016-03

Publications

Rauck RL, Oh DA, Singla N, Koch C, Parikh N, Nalamachu S, Yu J, James S. Pharmacokinetics of Fentanyl Sublingual Spray in Opioid-Naive Participants: Results of a Phase 1, Multiple Ascending Dose Study. Clin Drug Investig. 2018 Aug;38(8):715-726. doi: 10.1007/s40261-018-0658-9.
Rauck RL, Oh DA, Singla N, Koch C, Parikh N, Nalamachu S, Wilson D, Yu J, Vetticaden S. Pharmacokinetics and safety of fentanyl sublingual spray and fentanyl citrate intravenous: a multiple ascending dose study in opioid-naive healthy volunteers. Curr Med Res Opin. 2017 Nov;33(11):1921-1933. doi: 10.1080/03007995.2017.1371681. Epub 2017 Sep 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fentanyl	Other / unclassified	50 ug	Other
Subject	Fentanyl	Other / unclassified	100 ug	Other
Subject	Fentanyl	Other / unclassified	200 ug	Other
Subject	Fentanyl	Other / unclassified	400 ug	Other

Indications

No indication recorded.