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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients). The amount of nalbuphine levels in the blood will also be measured and the safety of the study drugs will be evaluated.
This study has 2 parts: Part A and Part B.
This study will be a single-dose, randomized, double-blind, active- and placebo-controlled, double dummy, 2-part, 7-way crossover study to determine the abuse potential of orally administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone solution and placebo, in non-dependent, recreational opioid users. The study will be conducted in a single clinical research unit (CRU).
The purpose of Part A is to find the appropriate doses (a low, intermediate, and high dose) of nalbuphine solution to use in Part B. Part A of the study has two visits to the research clinic: a screening visit and dose selection visit. The visits will involve a 2-night stay (3 days total) in the research clinic.
In the Main Study Treatment Phase in Part B, the total estimated duration between each dose of study drug is approximately up to 7 days, of which the subject will spend 3 days/2 nights in the research clinic and approximately up to 4 days at home.
The primary objective of the Main Study is to evaluate the abuse potential of orally administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone solution (the active comparator) and placebo in non-dependent, recreational opioid users.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo 150 mL flavored beverage |
|
| 90 mg nalbuphine HCl solution | Experimental | 90 mg nalbuphine HCl solution 9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage |
|
| 120 mg nalbuphine HCl solution | Experimental | 120 mg nalbuphine HCl solution 12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage |
|
| 150 mg nalbuphine HCl solution | Experimental | 150 mg nalbuphine HCl solution 15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage |
|
| 180 mg nalbuphine HCl solution | Experimental | 180 mg nalbuphine HCl solution 18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage |
|
| 270 mg nalbuphine HCl solution |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalbuphine HCl solution | Drug | nalbuphine solution administered at various strengths |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). | Only Part A of thie study was conducted because of closure the clinical research unit (CRU) before Part B could be initiated. Summary statistics are provided for C-max | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Development Officer | Trevi Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 001 | Toronto | Ontario | M5V 2T3 | Canada |
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Only Part A of this study was completed. Treatment arms summarized are those that were used on in Part A.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo 150 mL flavored beverage Placebo solution: Placebo |
| FG001 | 90 mg Nalbuphine HCl Solution | 90 mg nalbuphine HCl solution 9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| FG002 | 120 mg Nalbuphine HCl Solution | 120 mg nalbuphine HCl solution 12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| FG003 | 150 mg Nalbuphine HCl Solution | 150 mg nalbuphine HCl solution 15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| FG004 | 180 mg Nalbuphine HCl Solution | 180 mg nalbuphine HCl solution 18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| FG005 | 270 mg Nalbuphine HCl Solution | 270 mg nalbuphine HCl solution 27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| FG006 | Up to 405 mg Nalbuphine HCl Solution | Up to 405 mg nalbuphine HCl solution Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| FG007 | Up to 540 mg Nalbuphine HCl Solution | Up to 540 mg nalbuphine HCl solution Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo 150 mL flavored beverage Placebo solution: Placebo |
| BG001 | 90 mg Nalbuphine HCl Solution | 90 mg nalbuphine HCl solution 9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). | Only Part A of thie study was conducted because of closure the clinical research unit (CRU) before Part B could be initiated. Summary statistics are provided for C-max | C max | Posted | Mean | Standard Deviation | microgram/L | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose |
|
24 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 | Placebo | Placebo 150 mL flavored beverage Placebo solution: Placebo | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Sciascia, MD | Trevi Therapeutics | 203-304-2499 | thomas.sciascia@trevitherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 10, 2018 | Aug 8, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2019 | Aug 7, 2020 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Single-dose, randomized, double-blind, active- and placebo-controlled, double-dummy, 2-part, 7-way crossover study.
Part A: Dose selection phase Part B: Treatment Periods 1-7
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For each dosing cohort, an unblinded statistician, not otherwise involved in the study, will prepare a list of subject randomization numbers. These randomization numbers will be used to prepare individual subject doses. Sealed qualification code break envelopes will be available for each subject in case of emergency.
Upon completion of each cohort of subjects, the randomization codes for the completed subjects will be unblinded by the CRU pharmacy. After unblinding, the safety data will be reviewed to determine if dosing can proceed for the next planned dosing cohort,
270 mg nalbuphine HCl solution 27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage |
|
| Up to 405 mg nalbuphine HCl solution | Experimental | Up to 405 mg nalbuphine HCl solution Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage |
|
| Up to 540 mg nalbuphine HCl solution | Experimental | Up to 540 mg nalbuphine HCl solution Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage |
|
|
| Placebo solution | Drug | Placebo |
|
| BG002 | 120 mg Nalbuphine HCl Solution | 120 mg nalbuphine HCl solution 12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| BG003 | 150 mg Nalbuphine HCl Solution | 150 mg nalbuphine HCl solution 15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| BG004 | 180 mg Nalbuphine HCl Solution | 180 mg nalbuphine HCl solution 18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| BG005 | 270 mg Nalbuphine HCl Solution | 270 mg nalbuphine HCl solution 27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| BG006 | Up to 405 mg Nalbuphine HCl Solution | Up to 405 mg nalbuphine HCl solution Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| BG007 | Up to 540 mg Nalbuphine HCl Solution | Up to 540 mg nalbuphine HCl solution Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m**2 |
|
| OG002 | 120 mg Nalbuphine HCl Solution | 120 mg nalbuphine HCl solution 12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| OG003 | 150 mg Nalbuphine HCl Solution | 150 mg nalbuphine HCl solution 15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| OG004 | 180 mg Nalbuphine HCl Solution | 180 mg nalbuphine HCl solution 18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| OG005 | 270 mg Nalbuphine HCl Solution | 270 mg nalbuphine HCl solution 27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| OG006 | Up to 405 mg Nalbuphine HCl Solution | Up to 405 mg nalbuphine HCl solution Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
| OG007 | Up to 540 mg Nalbuphine HCl Solution | Up to 540 mg nalbuphine HCl solution Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths |
|
|
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 90 mg Nalbuphine HCl Solution | 90 mg nalbuphine HCl solution 9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | 120 mg Nalbuphine HCl Solution | 120 mg nalbuphine HCl solution 12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | 150 mg Nalbuphine HCl Solution | 150 mg nalbuphine HCl solution 15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | 180 mg Nalbuphine HCl Solution | 180 mg nalbuphine HCl solution 18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | 270 mg Nalbuphine HCl Solution | 270 mg nalbuphine HCl solution 27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths | 0 | 6 | 0 | 6 | 0 | 6 |
| EG006 | Up to 405 mg Nalbuphine HCl Solution | Up to 405 mg nalbuphine HCl solution Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths | 0 | 6 | 0 | 6 | 0 | 6 |
| EG007 | Up to 540 mg Nalbuphine HCl Solution | Up to 540 mg nalbuphine HCl solution Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths | 0 | 6 | 0 | 6 | 0 | 6 |
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