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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03624322
Study type Interventional
Source Impel NeuroPharma Inc.
Contact
Status Completed
Phase Phase 1
Start date August 5, 2018
Completion date October 3, 2018

See also
  Status Clinical Trial Phase
Not yet recruiting NCT02512705 - Medical Monitoring for Agitated Patients Pilot RCT - Medical Monitoring N/A
Terminated NCT03246620 - Oral Olanzapine Versus Haloperidol or Diazepam Phase 4
Not yet recruiting NCT05803642 - A Study of Olanzapine in Patients With Acute Agitation Phase 3