NCT03624322

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

Phase1 Randomized, Double-Blind, Placebo/Active-Controlled, SAD, 2-Way, Incomplete Block, 2-Period Crossover, Safety, Tolerability, PK/PD Study of 3 Doses INP105 (Olanzapine Delivered by I231 POD® Device) Nasal Spray in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Impel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, double-blind, placebo- and active-controlled, ascending-dose, 2-way, 2- period, incomplete block, crossover, Phase 1 trial to compare the safety, tolerability, PK and PD of 3 single doses of INP105 with the safety, tolerability, PK and PD of 1 dose of Zyprexa IM (5 mg) and 1 dose of oral Zyprexa Zydis (10 mg). Randomization for Periods 1 and 2 will occur for each subject on Day 1.

Conditions

• Acute Agitation

Interventions

Type	Name	Description
DRUG	Zyprexa IM	5mg
DRUG	Zydis	10mg orally disintegrating wafer
DRUG	INP105	Single, ascending doses of 5, 10, or 20mg capsules OLZ (olanzapine) or placebo (MCC)
DEVICE	I231 POD® Device	Precision Olfactory Delivery (POD) device

Timeline

• Start date: 2018-08-05
• Primary completion: 2018-10-03
• Completion: 2018-10-03
• First posted: 2018-08-10
• Last updated: 2018-10-04

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study
• FDA-regulated device study