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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03624322




Registration number
NCT03624322
Ethics application status
Date submitted
25/07/2018
Date registered
10/08/2018
Date last updated
4/10/2018

Titles & IDs
Public title
Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101
Scientific 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
Secondary ID [1] 0 0
INP105-101
Universal Trial Number (UTN)
Trial acronym
SNAP101
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Agitation 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zyprexa IM
Treatment: Drugs - Zydis
Treatment: Drugs - INP105
Treatment: Devices - I231 POD® Device

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)

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)


Treatment: Drugs: Zyprexa IM
5mg

Treatment: Drugs: Zydis
10mg orally disintegrating wafer

Treatment: Drugs: INP105
Single, ascending doses of 5, 10, or 20mg capsules OLZ (olanzapine) or placebo (MCC)

Treatment: Devices: I231 POD® Device
Precision Olfactory Delivery (POD) device

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability - AEs and SAEs as assessed from baseline by physical exam, ECG, vital signs, and clinical laboratory results
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
PK profile of OLZ INP105 Tmax - Tmax
Timepoint [2] 0 0
72 hours
Primary outcome [3] 0 0
PK profile of OLZ INP105 Cmax - Cmax
Timepoint [3] 0 0
72 hours
Primary outcome [4] 0 0
PK profile of Zyprexa IM Tmax - Tmax
Timepoint [4] 0 0
72 hours
Primary outcome [5] 0 0
PK profile of Zyprexa IM Cmax - Cmax
Timepoint [5] 0 0
72 hrs
Primary outcome [6] 0 0
PK profile of Zyprexa Zydis Tmax - Tmax
Timepoint [6] 0 0
72 hours
Primary outcome [7] 0 0
PK profile of Zyprexa Zydis Cmax - Cmax
Timepoint [7] 0 0
72 hours
Primary outcome [8] 0 0
PD effects of INP105 vs placebo - Changes in motor function measured by PD assessment compared to overall PK profile following ascending doses of INP105
Timepoint [8] 0 0
72 hours
Primary outcome [9] 0 0
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
Timepoint [9] 0 0
72 hours
Primary outcome [10] 0 0
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
Timepoint [10] 0 0
72 hours

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Impel NeuroPharma Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03624322
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen B Shrewsbury, MD
Address 0 0
Impel NeuroPharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications