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Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUF NT 15 mcg | Experimental | Period 1: One dose of SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil. |
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| Ketoconazole 400 mg, SUF NT 15 mcg | Experimental | Ketoconazole 400 mg administered once daily for three days. One dose of SUF NT 15 mcg was co-administered sublingually with the third (last) ketoconazole dose. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil NanoTab (SUF NT) 15 mcg | Drug | Period 1: One dose of SUF NT 15 mcg administered sublingually |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC (0-inf) | Total amount of sufentanil absorbed; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points. | 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours |
| Cmax | Maximum plasma concentration; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points. | 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela P. Palmer, MD, PhD | Talphera, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA | Lenexa | Kansas | 66219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SUF NT 15 mcg Followed by Ketoconazole 400 mg + SUF NT 15 mcg | Period 1: One SUF NT 15 mcg administered sublingually followed by Period 2. Period 2: Ketoconazole 400 mg given daily for three days; One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT 15 mcg dosing to block the opioid effects of the sufentanil. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SUF NT 15 mcg |
| |||||||||||||
| Ketoconazole 400 mg and SUF NT 15 mcg |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SUF NT 15 mcg Then 3 Days of Ketoconazole and SUF NT 15 mcg | Period 1: SUF NT 15 mcg administered once sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil. Period 2: Ketoconazole 400 mg given daily for three days. One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Subjects must have been between 18 and 45 years of age, inclusive |
| 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 | AUC (0-inf) | Total amount of sufentanil absorbed; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points. | 2 of the 19 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE) | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours |
|
Four days
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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 | SUF NT 15 mcg | One SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal 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 |
|---|---|
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg | Drug | Period 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day |
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| Count of Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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Ketoconazole 400 mg given orally daily for three days. One SUF NT 15 mcg is also co-administered sublingually with the third (last) ketoconazole dose. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil. |
|
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| Primary | Cmax | Maximum plasma concentration; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points. | 2 of the 19 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 | 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing. |
|
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| 0 |
| 19 |
| 5 |
| 19 |
| EG001 | Ketoconazole 400 mg + SUF NT 15 mcg | Ketoconazole 400 mg given daily for three days. One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil. | 0 | 18 | 4 | 18 |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Constipation | 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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| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Myalgia | 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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| Lethargy | Nervous system 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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| Photophobia | Eye disorders | MedDRA (11.0) | Non-systematic Assessment | All adverse events listed on this table are included regardless of relationship to study drug (s) |
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Requires prior approval from AcelRx Pharmaceuticals, Inc.