Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
NCT07921966, Phase 1, Not yet recruiting, Neurelis, Inc.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants | ClinicalTrials.gov |
| NCT number | NCT07921966 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 24 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Neurelis, Inc. | ClinicalTrials.gov |
| Conditions | Healthy Adult Participants | ClinicalTrials.gov |
| Interventions | NRL-1004 2.5 mg, ZYPREXA IM 10mg, NRL-1004 5.0 mg, NRL-1004 7.5 mg, NRL-1004 10.0 mg | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Pharmacokinetic parameters of olanzapine in plasma | Time zero to 14 days postdose | Maximum observed plasma concentration (Cmax) | ClinicalTrials.gov |
| Primary | Pharmacokinetic parameters of olanzapine in plasma | Time zero to 14 days postdose | Time to maximum plasma concentration (Tmax) | ClinicalTrials.gov |
| Primary | Pharmacokinetic parameters of olanzapine in plasma | Time zero to 14 days postdose | Area under the plasma concentration time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t) | ClinicalTrials.gov |
| Primary | Pharmacokinetic parameters of olanzapine in plasma | Time zero to 14 days postdose | AUC from time zero extrapolated to infinity (AUC0-inf) | ClinicalTrials.gov |
| Primary | Pharmacokinetic parameters of olanzapine in plasma | Time zero to 14 days postdose | Partial AUC from time zero to 2 hours postdose (AUC0-2 h) | ClinicalTrials.gov |
| Primary | Pharmacokinetic parameters of olanzapine in plasma | Time zero to 14 days postdose | Partial AUC from time zero to 24 hours postdose (AUC0-24 h) | ClinicalTrials.gov |
| Primary | Pharmacokinetic parameters of olanzapine in plasma | Time zero to 14 days postdose | Terminal phase half-life (t½) | ClinicalTrials.gov |
| Primary | Pharmacokinetic parameters of olanzapine in plasma | Time zero to 14 days postdose | Terminal phase rate constant (λz) | ClinicalTrials.gov |
| Primary | Pharmacokinetic parameters of olanzapine in plasma | Time zero to 14 days postdose | Apparent clearance (CL/F) | ClinicalTrials.gov |
| Primary | Pharmacokinetic parameters of olanzapine in plasma | Time zero to 14 days postdose | Apparent volume of distribution (Vz/F) | ClinicalTrials.gov |
| Primary | Pharmacokinetic parameters of olanzapine in plasma | Time zero to 14 days postdose | Relative bioavailability (Frel) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)