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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
5mg
10mg orally disintegrating wafer
Single, ascending doses of 5, 10, or 20mg capsules OLZ (olanzapine) or placebo (MCC)
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Safety and tolerability
AEs and SAEs as assessed from baseline by physical exam, ECG, vital signs, and clinical laboratory results
Time frame: 30 days
PK profile of OLZ INP105 Tmax
Tmax
Time frame: 72 hours
PK profile of OLZ INP105 Cmax
Cmax
Time frame: 72 hours
PK profile of Zyprexa IM Tmax
Tmax
Time frame: 72 hours
PK profile of Zyprexa IM Cmax
Cmax
Time frame: 72 hrs
PK profile of Zyprexa Zydis Tmax
Tmax
Time frame: 72 hours
PK profile of Zyprexa Zydis Cmax
Cmax
Time frame: 72 hours
PD effects of INP105 vs placebo
Changes in motor function measured by PD assessment compared to overall PK profile following ascending doses of INP105
Time frame: 72 hours
PD effects of Zyprexa IM
Changes in motor function measured by PD assessment compared to overall PK profile following a single dose of 5mg of Zyprexa IM
Time frame: 72 hours
PD effects of Zyprexa Zydis
Changes in motor function measured by PD assessment compared to overall PK profile following a single 10mg dose of Zyprexa Zydis oral disintegrating wafer
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Precision Olfactory Delivery (POD) device
Time frame: 72 hours