Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101

Phase 1 Completed 38 enrolled Impel Pharmaceuticals

RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INP105, which is an investigational drug-device combination product comprised of the drug component OLZ administered by a Precision Olfactory Delivery (POD®) nasal spray device (I231 POD® Device). The proposed indication for INP105 is the treatment of acute agitation associated with schizophrenia and bipolar I disorder.

Timeline

Start: 2018-08-05
Primary completion: 2018-10-03
Completion: 2018-10-03

Publications

Shrewsbury SB, Hocevar-Trnka J, Satterly KH, Craig KL, Lickliter JD, Hoekman J. The SNAP 101 Double-Blind, Placebo/Active-Controlled, Safety, Pharmacokinetic, and Pharmacodynamic Study of INP105 (Nasal Olanzapine) in Healthy Adults. J Clin Psychiatry. 2020 Jun 30;81(4):19m13086. doi: 10.4088/JCP.19m13086.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olanzapine	Small molecule	5 mg	Intranasal
Subject	Olanzapine	Small molecule	10 mg	Intranasal
Subject	Olanzapine	Small molecule	15 mg	Intranasal
Subject	Olanzapine	Small molecule	20 mg	Intranasal

Indications

No indication recorded.