Trial · NCT03624322
Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101
NCT03624322, Phase 1, Completed, Impel Pharmaceuticals
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101. Trials, record NCT03624322. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03624322
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101
- NCT number
- NCT03624322
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 38 participants, actual
- Lead sponsor
- Impel Pharmaceuticals
- Conditions
- Acute Agitation
- Interventions
- Zyprexa IM, Zydis, INP105, I231 POD® Device
- First posted
- 2018-08-10
- Last updated
- 2018-10-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability | 30 days | AEs and SAEs as assessed from baseline by physical exam, ECG, vital signs, and clinical laboratory results |
| Primary | PK profile of OLZ INP105 Tmax | 72 hours | Tmax |
| Primary | PK profile of OLZ INP105 Cmax | 72 hours | Cmax |
| Primary | PK profile of Zyprexa IM Tmax | 72 hours | Tmax |
| Primary | PK profile of Zyprexa IM Cmax | 72 hrs | Cmax |
| Primary | PK profile of Zyprexa Zydis Tmax | 72 hours | Tmax |
| Primary | PK profile of Zyprexa Zydis Cmax | 72 hours | Cmax |
| Primary | PD effects of INP105 vs placebo | 72 hours | Changes in motor function measured by PD assessment compared to overall PK profile following ascending doses of INP105 |
| Primary | PD effects of Zyprexa IM | 72 hours | Changes in motor function measured by PD assessment compared to overall PK profile following a single dose of 5mg of Zyprexa IM |
| Primary | PD effects of Zyprexa Zydis | 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 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32609960 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03624322
GET https://conductscience.org/api/trials/v1/NCT03624322/registered