Trial · NCT04759768
Pharmacokinetic Evaluation of Intranasal Nalmefene
NCT04759768, Phase 1, Completed, Opiant Pharmaceuticals Inc; results first posted 2024-08-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetic Evaluation of Intranasal Nalmefene. Trials, record NCT04759768. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04759768
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic Evaluation of Intranasal Nalmefene
- NCT number
- NCT04759768
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 68 participants, actual
- Lead sponsor
- Opiant Pharmaceuticals Inc
- Conditions
- Pharmacokinetics
- Interventions
- Nalmefene Hydrochloride, Nalmefene
- First posted
- 2021-02-18
- Last updated
- 2024-08-13
- Results first posted
- 2024-08-13
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 IN to IM |
| Primary | Time to Maximum Plasma Concentration (Tmax) | 48 hours | Time to maximum concentration of plasma nalmefene comparing IN to IM |
| Primary | Area Under the Curve (AUC-inf) | 48 hours | Area under the curve of plasma nalmefene comparing IN to IM |
| Primary | Half-life (t1/2) | 48 hours | Half life of plasma nalmefene comparing IN to IM |
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-inf) | 48 hours | hour*ng/mL | MEAN | |
| PRIMARY | Half-life (t1/2) | 48 hours | hour | MEAN |
Source ClinicalTrials.gov
Results by group8
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 | 12.2 | Standard Deviation 6.71 | ng/ml | |
| Maximum Plasma Concentration (Cmax) | Intramuscular Nalmefene | 1.77 | Standard Deviation 1.18 | ng/ml | |
| Time to Maximum Plasma Concentration (Tmax) | Intranasal Nalmefene | 0.25 | Full Range 0.0833 to 2 | hours | |
| Time to Maximum Plasma Concentration (Tmax) | Intramuscular Nalmefene | 0.333 | Full Range 0.117 to 18 | hours | |
| Area Under the Curve (AUC-inf) | Intranasal Nalmefene | 41.5 | Standard Deviation 8.45 | hour*ng/mL | |
| Area Under the Curve (AUC-inf) | Intramuscular Nalmefene | 17.0 | Standard Deviation 3.13 | hour*ng/mL | |
| Half-life (t1/2) | Intranasal Nalmefene | 11.4 | Standard Deviation 2.37 | hour | |
| Half-life (t1/2) | Intramuscular Nalmefene | 10.6 | Standard Deviation 1.95 | hour |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (1 Day) | STARTED | Intranasal Nalmefene Then Intramuscular Nalmefene | 34 | |
| First Intervention (1 Day) | STARTED | Intramuscular Nalmefene Then Intranasal Nalmefene | 34 | |
| First Intervention (1 Day) | COMPLETED | Intranasal Nalmefene Then Intramuscular Nalmefene | 34 | |
| First Intervention (1 Day) | COMPLETED | Intramuscular Nalmefene Then Intranasal Nalmefene | 34 | |
| First Intervention (1 Day) | NOT COMPLETED | Intranasal Nalmefene Then Intramuscular Nalmefene | 0 | |
| First Intervention (1 Day) | NOT COMPLETED | Intramuscular Nalmefene Then Intranasal Nalmefene | 0 | |
| Washout (7 Days) | STARTED | Intranasal Nalmefene Then Intramuscular Nalmefene | 34 | |
| Washout (7 Days) | STARTED | Intramuscular Nalmefene Then Intranasal Nalmefene | 34 | |
| Washout (7 Days) | COMPLETED | Intranasal Nalmefene Then Intramuscular Nalmefene | 34 | |
| Washout (7 Days) | COMPLETED | Intramuscular Nalmefene Then Intranasal Nalmefene | 32 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events8
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 | nasal discomfort | Respiratory, thoracic and mediastinal disorders | Intranasal Nalmefene | 37 | 66 | |
| other | nasal discomfort | Respiratory, thoracic and mediastinal disorders | Intramuscular Nalmefene | 0 | 68 | |
| other | headache | Nervous system disorders | Intranasal Nalmefene | 3 | 66 | |
| other | headache | Nervous system disorders | Intramuscular Nalmefene | 4 | 68 | |
| other | nausea | Gastrointestinal disorders | Intranasal Nalmefene | 2 | 66 | |
| other | nausea | Gastrointestinal disorders | Intramuscular Nalmefene | 4 | 68 | |
| other | dizziness | Nervous system disorders | Intranasal Nalmefene | 4 | 66 | |
| other | dizziness | Nervous system disorders | Intramuscular Nalmefene | 1 | 68 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intranasal Nalmefene | 0 | 66 |
| Total, all-cause mortality | Intramuscular Nalmefene | 0 | 68 |
| Total, other adverse events | Intranasal Nalmefene | 42 | 66 |
| Total, other adverse events | Intramuscular Nalmefene | 8 | 68 |
| Total, serious adverse events | Intranasal Nalmefene | 0 | 66 |
| Total, serious adverse events | Intramuscular Nalmefene | 0 | 68 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intranasal Nalmefene vs Intramuscular Nalmefene: deaths from any cause | Trial comparisons |
| Intranasal Nalmefene vs Intramuscular Nalmefene: serious adverse events | Trial comparisons |
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/NCT04759768
GET https://conductscience.org/api/trials/v1/NCT04759768/registered