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Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101 (SNAP101)

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ClinicalTrials.gov Identifier: NCT03624322
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Impel NeuroPharma Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Agitation Drug: Zyprexa IM Drug: Zydis Drug: INP105 Device: I231 POD® Device Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Period 1 (n=36) assignment to 1 of 2 reference therapy treatment groups over 3 cohorts Period 2 (n=36) assignment to 1 of 3 IP treatment groups over 3 cohorts
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind, placebo-controlled
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 5, 2018
Estimated Primary Completion Date : September 26, 2018
Estimated Study Completion Date : October 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Period 1
Period 1 (n=36) assignment to 1 of 2 reference therapy treatment groups (Zyprexa 5mg IM or Zydis 10mg orally disintegrating wafer, 10mg) over 3 cohorts (single dose)
Drug: Zyprexa IM
5mg

Drug: Zydis
10mg orally disintegrating wafer
Other Name: Zyprexa Zydis

Experimental: Period 2
Period 2 (n=36) assignment to 1 of 3 IP treatment groups (INP105 of 5, 10, or 20mg or placebo) administered with the I231 POD® Device) over 3 cohorts (single dose)
Drug: INP105
Single, ascending doses of 5, 10, or 20mg capsules OLZ (olanzapine) or placebo (MCC)
Other Name: OLZ or placebo

Device: I231 POD® Device
Precision Olfactory Delivery (POD) device
Other Name: POD®




Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 30 days ]
    AEs and SAEs as assessed from baseline by physical exam, ECG, vital signs, and clinical laboratory results

  2. PK profile of OLZ INP105 Tmax [ Time Frame: 72 hours ]
    Tmax

  3. PK profile of OLZ INP105 Cmax [ Time Frame: 72 hours ]
    Cmax

  4. PK profile of Zyprexa IM Tmax [ Time Frame: 72 hours ]
    Tmax

  5. PK profile of Zyprexa IM Cmax [ Time Frame: 72 hrs ]
    Cmax

  6. PK profile of Zyprexa Zydis Tmax [ Time Frame: 72 hours ]
    Tmax

  7. PK profile of Zyprexa Zydis Cmax [ Time Frame: 72 hours ]
    Cmax

  8. PD effects of INP105 vs placebo [ Time Frame: 72 hours ]
    Changes in motor function measured by PD assessment compared to overall PK profile following ascending doses of INP105

  9. PD effects of Zyprexa IM [ Time Frame: 72 hours ]
    Changes in motor function measured by PD assessment compared to overall PK profile following a single dose of 5mg of Zyprexa IM

  10. PD effects of Zyprexa Zydis [ Time Frame: 72 hours ]
    Changes in motor function measured by PD assessment compared to overall PK profile following a single 10mg dose of Zyprexa Zydis oral disintegrating wafer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Adult male (N=at least 9) and female (N=at least 9) 18 to 55 years of age (inclusive) at Screening
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adult male (N=at least 9) and female (N=at least 9) 18 to 55 years of age (inclusive) at Screening, in good general health, with no significant medical history and no clinically significant abnormalities on physical examination at Screening or before first dose of IP.
  2. Subjects must have a Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
  3. Negative urine drug screen/alcohol breath test at Screening and Day -1. Repeat tests may be performed if false positive results are suspected.
  4. Subjects must have the ability and willingness to attend the necessary visits at the study centre.
  5. Written informed consent signed prior to entry into the study.
  6. Female subjects of childbearing potential, and male subjects and their partners, must agree to use adequate contraception, defined as complete abstinence, documented evidence of surgical sterilization or condom plus approved contraceptive method

Exclusion Criteria:

  1. Known hypersensitivity to Zyprexa IM, Zyprexa Zydis or any of the ingredients in them or in INP105 or the placebo.
  2. Recently (within 3 months) or currently taking Zyprexa (any formulation).
  3. Subjects taking medications known to inhibit or induce CYP1A2 at any time during the study period, and any subjects taking prescription medications, over the counter medications or supplements that, in the opinion of the Investigator, may impact the subject's response to INP105 or impact the subject's participation in the study. Oral contraceptives are permitted.
  4. Subjects with medical history of hypotension or currently taking anti-hypertensives at Screening or throughout the study.
  5. Current or recent smokers (<3 months since quitting); inadvertent one-off smokers and social smokers will also be excluded.
  6. Females who are pregnant or lactating.
  7. Subjects with any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will comply with the study.
  8. Abnormal and clinically significant laboratory test results.
  9. History or presence of alcohol or drug abuse within the 2 years prior to the first IP administration.
  10. Blood donation or significant blood loss within 60 days prior to the first IP administration.
  11. Plasma donation within 7 days prior to the first IP administration.
  12. Administration of IP in another trial within 30 days or 5 half-lives (whichever is longer) prior to the first IP administration.
  13. Significant surgery within the past 3 months prior to the first IP administration determined by the Investigator to be clinically relevant.
  14. Failure to satisfy the Investigator of fitness to participate for any other reason.
  15. Acute illness within 30 days prior to Day 1. Subjects with minor viral illnesses (for example, upper respiratory tract infection) within 30 days prior to Day 1 may be randomized if all symptoms are resolved by admission and at the discretion of the Investigator.
  16. Any nasal congestion, deviated septum, or physical blockage in either nostril.
  17. Positive for human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624322


Contacts
Contact: Jacki Campbell, CCRA, CCRP +14252601238 jcampbell@impelnp.com
Contact: Meghan I Swardstrom +12062910375 mswardstrom@impelnp.com

Locations
Australia, Victoria
Nucleus Network Pty Ltd Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Jeffrey Wong, MSc    +61 3 8593 9822    J.Wong@nucleusnetwork.com.au   
Sponsors and Collaborators
Impel NeuroPharma Inc.
Investigators
Study Director: Stephen B Shrewsbury, MD Impel NeuroPharma
Principal Investigator: Niquita Tugiono, MD Nucleus Network Pty Ltd

Responsible Party: Impel NeuroPharma Inc.
ClinicalTrials.gov Identifier: NCT03624322     History of Changes
Other Study ID Numbers: INP105-101
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Impel NeuroPharma Inc.:
Agitation
Schizophrenia
Bipolar I disorder
OLZ
Olanzapine
Zyprexa
POD® device

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents