Trial · NCT05219669
Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
NCT05219669, Phase 1, Completed, Opiant Pharmaceuticals Inc; results first posted 2024-08-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens. Trials, record NCT05219669. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05219669
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
- NCT number
- NCT05219669
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Opiant Pharmaceuticals Inc
- Conditions
- Opioid Overdose
- Interventions
- Nalmefene Hydrochloride
- First posted
- 2022-02-02
- Last updated
- 2024-08-05
- Results first posted
- 2024-08-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) | 48 hours | Maximum concentration of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril |
| Primary | Time to Maximum Plasma Concentration (Tmax) | 48 hours | Time to maximum concentration of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril |
| Primary | Area Under the Curve (AUC) | 48 hours | Area under the curve of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril |
| Primary | Half-life (t1/2) | 48 hours | Half life of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Plasma Concentration (Cmax) | 48 hours | ng/ml | MEAN | |
| PRIMARY | Time to Maximum Plasma Concentration (Tmax) | 48 hours | hours | MEDIAN | |
| PRIMARY | Area Under the Curve (AUC) | 48 hours | AUCinf (ng·h/mL) | MEAN | |
| PRIMARY | Half-life (t1/2) | 48 hours | hour | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Plasma Concentration (Cmax) | Intranasal Nalmefene 1 Spray in 1 Nostril | 10.8 | Standard Deviation 4.87 | ng/ml | |
| Maximum Plasma Concentration (Cmax) | Intranasal Nalmefene 2 Sprays in 1 Nostril | 18.9 | Standard Deviation 11.2 | ng/ml | |
| Maximum Plasma Concentration (Cmax) | Intranasal Nalmefene 1 Spray in Each Nostril | 22.2 | Standard Deviation 13.5 | ng/ml | |
| Time to Maximum Plasma Concentration (Tmax) | Intranasal Nalmefene 1 Spray in 1 Nostril | 0.267 | Full Range 0.167 to 2.03 | hours | |
| Time to Maximum Plasma Concentration (Tmax) | Intranasal Nalmefene 2 Sprays in 1 Nostril | 0.25 | Full Range 0.117 to 3 | hours | |
| Time to Maximum Plasma Concentration (Tmax) | Intranasal Nalmefene 1 Spray in Each Nostril | 0.25 | Full Range 0.117 to 2.03 | hours | |
| Area Under the Curve (AUC) | Intranasal Nalmefene 1 Spray in 1 Nostril | 46.8 | Standard Deviation 10.1 | AUCinf (ng·h/mL) | |
| Area Under the Curve (AUC) | Intranasal Nalmefene 2 Sprays in 1 Nostril | 85.7 | Standard Deviation 18.7 | AUCinf (ng·h/mL) | |
| Area Under the Curve (AUC) | Intranasal Nalmefene 1 Spray in Each Nostril | 89.5 | Standard Deviation 17.0 | AUCinf (ng·h/mL) | |
| Half-life (t1/2) | Intranasal Nalmefene 1 Spray in 1 Nostril | 11.4 | Standard Deviation 2.51 | hour |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow90
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (1 Day) | STARTED | Sequence 1 | 4 | |
| Period 1 (1 Day) | STARTED | Sequence 2 | 4 | |
| Period 1 (1 Day) | STARTED | Sequence 3 | 4 | |
| Period 1 (1 Day) | STARTED | Sequence 4 | 4 | |
| Period 1 (1 Day) | STARTED | Sequence 5 | 4 | |
| Period 1 (1 Day) | STARTED | Sequence 6 | 4 | |
| Period 1 (1 Day) | COMPLETED | Sequence 1 | 4 | |
| Period 1 (1 Day) | COMPLETED | Sequence 2 | 4 | |
| Period 1 (1 Day) | COMPLETED | Sequence 3 | 3 | |
| Period 1 (1 Day) | COMPLETED | Sequence 4 | 4 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 participant flowAdverse events18
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 |
|---|---|---|---|---|---|---|
| other | Rhinalgia | Respiratory, thoracic and mediastinal disorders | Intranasal Nalmefene 1 Spray in 1 Nostril | 3 | 23 | |
| other | Rhinalgia | Respiratory, thoracic and mediastinal disorders | Intranasal Nalmefene 2 Sprays in 1 Nostril | 6 | 24 | |
| other | Rhinalgia | Respiratory, thoracic and mediastinal disorders | Intranasal Nalmefene 1 Spray in Each Nostril | 2 | 23 | |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Intranasal Nalmefene 1 Spray in 1 Nostril | 1 | 23 | |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Intranasal Nalmefene 2 Sprays in 1 Nostril | 4 | 24 | |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Intranasal Nalmefene 1 Spray in Each Nostril | 1 | 23 | |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Intranasal Nalmefene 1 Spray in 1 Nostril | 1 | 23 | |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Intranasal Nalmefene 2 Sprays in 1 Nostril | 3 | 24 | |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Intranasal Nalmefene 1 Spray in Each Nostril | 3 | 23 | |
| other | Nausea | Gastrointestinal disorders | Intranasal Nalmefene 1 Spray in 1 Nostril | 1 | 23 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intranasal Nalmefene 1 Spray in 1 Nostril | 0 | 23 |
| Total, all-cause mortality | Intranasal Nalmefene 2 Sprays in 1 Nostril | 0 | 24 |
| Total, all-cause mortality | Intranasal Nalmefene 1 Spray in Each Nostril | 0 | 23 |
| Total, other adverse events | Intranasal Nalmefene 1 Spray in 1 Nostril | 9 | 23 |
| Total, other adverse events | Intranasal Nalmefene 2 Sprays in 1 Nostril | 16 | 24 |
| Total, other adverse events | Intranasal Nalmefene 1 Spray in Each Nostril | 12 | 23 |
| Total, serious adverse events | Intranasal Nalmefene 1 Spray in 1 Nostril | 0 | 23 |
| Total, serious adverse events | Intranasal Nalmefene 2 Sprays in 1 Nostril | 0 | 24 |
| Total, serious adverse events | Intranasal Nalmefene 1 Spray in Each Nostril | 0 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37496452 | 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/NCT05219669
GET https://conductscience.org/api/trials/v1/NCT05219669/flow?page=2