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

NCT03624322 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-10-04

No results posted yet for this study

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.

Conditions

  • Acute Agitation

Interventions

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

Sponsors & Collaborators

  • Impel Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Stephen B Shrewsbury, MD · Impel NeuroPharma

  • Niquita Tugiono, MD · Nucleus Network Pty Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-05
Primary Completion
2018-10-03
Completion
2018-10-03
FDA Drug
Yes
FDA Device
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03624322 on ClinicalTrials.gov