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Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg | Experimental | Period 1: Single dose of SUF NT 15 mcg Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose of SUF NT 15 mcg | Drug |
| ||
| 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1. For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3 | 24 hours in Treatment A, 37 hours in Treatment B |
| Time to Steady State | Steady state, for the cohort, was assessed using Helmert's method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p >0.05) | 24 hours |
| CST½ | the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration | 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra K. Willsie, D.O. | PRA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA | Lenexa | Kansas | 66219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25544247 | Background | Willsie SK, Evashenk MA, Hamel LG, Hwang SS, Chiang YK, Palmer PP. Pharmacokinetic properties of single- and repeated-dose sufentanil sublingual tablets in healthy volunteers. Clin Ther. 2015 Jan 1;37(1):145-55. doi: 10.1016/j.clinthera.2014.11.001. Epub 2014 Dec 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15mcg | Arm 1/Period 1: Single dose of SUF NT 15 mcg Subjects received oral naltrexone 50 mg approximately 14 and 2 hours before and 10 hours after the SUF NT dosing Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg Subjects received oral naltrexone 50 mg approximately 2 hours before and 10, 22, and 34 hours after the first dose of SUF NT in Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single Dose of SUF NT 15 mcg |
| |||||||||||||
| 40 Consecutive Doses of SUF 15 mcg |
|
One patient was withdrawn after Period 1 due to non-compliance
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| ID | Title | Description |
|---|---|---|
| BG000 | One Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15 mcg | Arm 1/Period 1: Single dose of SUF NT 15 mcg Single dose of SUF NT 15 mcg Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg 40 consecutive doses of SUF NT 15 mcg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax | For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1. For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3 | 2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE) | Posted | Mean | Standard Deviation | pg/mL | 24 hours in Treatment A, 37 hours in Treatment B |
|
AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Dose of SUF NT 15 mcg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photophobia | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Palmer, MD, PhD | AcelRx Pharmaceuticals, Inc. | 650-216-3504 | ppalmer@acelrx.com |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
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|
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Primary | Time to Steady State | Steady state, for the cohort, was assessed using Helmert's method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p >0.05) | 2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE) | Posted | Number | hours | 24 hours |
|
|
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| Primary | CST½ | the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration | 2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE) | Posted | Median | Full Range | hours | 24 |
|
|
|
| 0 |
| 40 |
| 5 |
| 40 |
| EG001 | 40 Consecutive Doses of SUF NT 15 mcg | 0 | 39 | 18 | 39 |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Feeling jittery | General disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Syncope vasovagal | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment | All adverse events listed in the above table are included regardless of relationship to study drug |
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Sponsor must be able to review any publications prior to publication