Acute AgitationPhase 1SNAP101NCT03624322
Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101
A Phase 1 study testing Zyprexa IM, Zydis and INP105 in people with Acute Agitation, run by Impel Pharmaceuticals at 1 site in Australia.
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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Agitation
- What is being tested?
- Zyprexa IM, Zydis and INP105
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Aug 2018to 3 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Subjects must have a Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
- Negative urine drug screen/alcohol breath test at Screening and Day -1. Repeat tests may be performed if false positive results are suspected.
- Subjects must have the ability and willingness to attend the necessary visits at the study centre.
- Written informed consent signed prior to entry into the study.
- 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
Who cannot join
- Known hypersensitivity to Zyprexa IM, Zyprexa Zydis or any of the ingredients in them or in INP105 or the placebo.
- Recently (within 3 months) or currently taking Zyprexa (any formulation).
- 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.
- Subjects with medical history of hypotension or currently taking anti-hypertensives at Screening or throughout the study.
- Current or recent smokers (<3 months since quitting); inadvertent one-off smokers and social smokers will also be excluded.
- Females who are pregnant or lactating.
Show all 17Show fewer
- 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.
- Abnormal and clinically significant laboratory test results.
- History or presence of alcohol or drug abuse within the 2 years prior to the first IP administration.
- Blood donation or significant blood loss within 60 days prior to the first IP administration.
- Plasma donation within 7 days prior to the first IP administration.
- Administration of IP in another trial within 30 days or 5 half-lives (whichever is longer) prior to the first IP administration.
- Significant surgery within the past 3 months prior to the first IP administration determined by the Investigator to be clinically relevant.
- Failure to satisfy the Investigator of fitness to participate for any other reason.
- 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.
- Any nasal congestion, deviated septum, or physical blockage in either nostril.
- Positive for human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Agitation
- Being tested
- Zyprexa IM, Zydis, INP105, I231 POD® Device
- Keywords
- Agitation, Schizophrenia, Bipolar I disorder, OLZ, Olanzapine, Zyprexa, POD® device
- Medical subject headings
- Psychomotor Agitation, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zyprexa IMDrug
5mg
ZydisDrug
Also called Zyprexa Zydis
10mg orally disintegrating wafer
INP105Drug
Also called OLZ or placebo
Single, ascending doses of 5, 10, or 20mg capsules OLZ (olanzapine) or placebo (MCC)
I231 POD® DeviceDevice
Also called POD®
Precision Olfactory Delivery (POD) device
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Active comparator | 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) Receives: Drug: Zyprexa IM; Drug: Zydis |
| Period 2 | Experimental | 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) Receives: Drug: INP105; Device: I231 POD® Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
AEs and SAEs as assessed from baseline by physical exam, ECG, vital signs, and clinical laboratory results
Measured: 30 days
PK profile of OLZ INP105 Tmax
Tmax
Measured: 72 hours
PK profile of OLZ INP105 Cmax
Cmax
Measured: 72 hours
PK profile of Zyprexa IM Tmax
Tmax
Measured: 72 hours
PK profile of Zyprexa IM Cmax
Cmax
Measured: 72 hrs
PK profile of Zyprexa Zydis Tmax
Tmax
Measured: 72 hours
PK profile of Zyprexa Zydis Cmax
Cmax
Measured: 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
Measured: 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
Measured: 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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start5 Aug 2018
- Primary completion3 Oct 2018
- Study completion3 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen B Shrewsbury, MD, Study director, Impel NeuroPharmaNiquita Tugiono, MD, Principal investigator, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624322
- Sponsor's protocol ID
- INP105-101
- Acronym
- SNAP101
- Status last verified
- Aug 2018
- First submitted
- 25 Jul 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
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):19m13086. doi: 10.4088/JCP.19m13086.
PubMed 32609960
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03624322
- Acronym / sponsor ID
- SNAP101 / INP105-101
- Conditions
- Acute Agitation
- Keywords
- Agitation, Schizophrenia, Bipolar I disorder, OLZ, Olanzapine, Zyprexa, POD® device
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Impel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2018 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Active comparator | Drug: Zyprexa IM, Drug: ZydisPeriod 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) |
| Period 2 | Experimental | Drug: INP105, Device: I231 POD® DevicePeriod 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) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
- Subjects must have a Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
- Negative urine drug screen/alcohol breath test at Screening and Day -1. Repeat tests may be performed if false positive results are suspected.
- Subjects must have the ability and willingness to attend the necessary visits at the study centre.
- Written informed consent signed prior to entry into the study.
Key exclusion criteria (17 listed)
- Known hypersensitivity to Zyprexa IM, Zyprexa Zydis or any of the ingredients in them or in INP105 or the placebo.
- Recently (within 3 months) or currently taking Zyprexa (any formulation).
- 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.
- Subjects with medical history of hypotension or currently taking anti-hypertensives at Screening or throughout the study.
- Current or recent smokers (<3 months since quitting); inadvertent one-off smokers and social smokers will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zyprexa IM5mg | Drug | Period 1 |
| ZydisAlso: Zyprexa Zydis10mg orally disintegrating wafer | Drug | Period 1 |
| INP105Also: OLZ or placeboSingle, ascending doses of 5, 10, or 20mg capsules OLZ (olanzapine) or placebo (MCC) | Drug | Period 2 |
| I231 POD® DeviceAlso: POD®Precision Olfactory Delivery (POD) device | Device | Period 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Derived from this study: PubMed 32609960Shrewsbury 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):19m13086. doi: 10.4088/JCP.19m13086.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen B Shrewsbury, MD study director
Impel NeuroPharma
Niquita Tugiono, MD principal investigator
Nucleus Network Pty Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zyprexa IM, Zydis and INP105 in people with Acute Agitation, run by Impel Pharmaceuticals at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 30 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03624322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2018.