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Trial record 1 of 1 for:    NCT03624322
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Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101 (SNAP101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03624322
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Impel NeuroPharma Inc.

Tracking Information
First Submitted Date  ICMJE July 25, 2018
First Posted Date  ICMJE August 10, 2018
Last Update Posted Date October 4, 2018
Actual Study Start Date  ICMJE August 5, 2018
Actual Primary Completion Date October 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
  • Safety and tolerability [ Time Frame: 30 days ]
    AEs and SAEs as assessed from baseline by physical exam, ECG, vital signs, and clinical laboratory results
  • PK profile of OLZ INP105 Tmax [ Time Frame: 72 hours ]
    Tmax
  • PK profile of OLZ INP105 Cmax [ Time Frame: 72 hours ]
    Cmax
  • PK profile of Zyprexa IM Tmax [ Time Frame: 72 hours ]
    Tmax
  • PK profile of Zyprexa IM Cmax [ Time Frame: 72 hrs ]
    Cmax
  • PK profile of Zyprexa Zydis Tmax [ Time Frame: 72 hours ]
    Tmax
  • PK profile of Zyprexa Zydis Cmax [ Time Frame: 72 hours ]
    Cmax
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
  • Safety and tolerability as assessed by adverse events [ Time Frame: 30 days ]
    AEs and SAEs
  • Safety and tolerability as assessed by physical exam [ Time Frame: 30 days ]
    Changes from baseline
  • PK profile of OLZ INP105 [ Time Frame: 72 hours ]
    Tmax
  • PK profile of OLZ INP105 [ Time Frame: 72 hours ]
    Cmax
  • PK profile of Zyprexa IM [ Time Frame: 72 hours ]
    Tmax
  • PK profile of Zyprexa IM [ Time Frame: 72 hrs ]
    Cmax
  • PK profile of Zyprexa Zydis [ Time Frame: 72 hours ]
    Tmax
  • PK profile of Zyprexa Zydis [ Time Frame: 72 hours ]
    Cmax
  • 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
  • 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 or 10mg of Zyprexa IM
  • 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
PK/PD relationship of INP105 [ Time Frame: 72 hours ]
Measured by dose-comparison response of three single-ascending-doses
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Acute Agitation
Intervention  ICMJE
  • Drug: Zyprexa IM
    5mg
  • Drug: Zydis
    10mg orally disintegrating wafer
    Other Name: Zyprexa Zydis
  • 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®
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: Zyprexa IM
    • Drug: 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)
    Interventions:
    • Drug: INP105
    • Device: I231 POD® Device
Publications * Shrewsbury SB, Hocevar-Trnka J, Satterly KH, Craig KL, Lickliter JD, Hoekman J. The SNAP 101 Double-Blind, Placebo/Active-Controlled, Safety, Pharmacokinetic, and Pharmacodynamic Study of INP105 (Nasal Olanzapine) in Healthy Adults. J Clin Psychiatry. 2020 Jun 30;81(4). pii: 19m13086. doi: 10.4088/JCP.19m13086.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2018)
38
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2018)
36
Actual Study Completion Date  ICMJE October 3, 2018
Actual Primary Completion Date October 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
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
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03624322
Other Study ID Numbers  ICMJE INP105-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Impel NeuroPharma Inc.
Study Sponsor  ICMJE Impel NeuroPharma Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stephen B Shrewsbury, MD Impel NeuroPharma
Principal Investigator: Niquita Tugiono, MD Nucleus Network Pty Ltd
PRS Account Impel NeuroPharma Inc.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP