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This study is designed to compare TRV130 to placebo and morphine to learn about its effects on pain relief and side effects.
This study will explore the pharmacokinetics, pharmacodynamics (PD), safety and tolerability of TRV130.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRV130 1.5 mg | Experimental | TRV130 1.5 mg IV x 1 dose |
|
| TRV130 3 mg | Experimental | TRV130 3 mg IV x 1 dose |
|
| TRV130 4.5 mg | Experimental | TRV130 4.5 mg IV x 1 dose |
|
| Morphine | Active Comparator | Morphine 10 mg IV x 1 dose |
|
| Placebo | Placebo Comparator | Dextrose 5% in water IV x 1 dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRV130 1.5 mg | Drug | TRV130 1.5 mg IV x 1 dose |
| |
| TRV130 3 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Cold Pain Test | 8 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilatory Response to Hypercapnia | 4 hours postdose | |
| Pupillometry | 8 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David G Soergel, MD | Trevena Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRI Lifetree | Salt Lake City | Utah | 84106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24954166 | Derived | Soergel DG, Subach RA, Burnham N, Lark MW, James IE, Sadler BM, Skobieranda F, Violin JD, Webster LR. Biased agonism of the mu-opioid receptor by TRV130 increases analgesia and reduces on-target adverse effects versus morphine: A randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Pain. 2014 Sep;155(9):1829-1835. doi: 10.1016/j.pain.2014.06.011. Epub 2014 Jun 19. |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C586842 | ((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Drug |
TRV130 3 mg IV x 1 dose |
|
| TRV130 4.5 mg | Drug | TRV130 4.5 mg IV x 1 dose |
|
| Morphine 10 mg | Drug | Morphine 10 mg IV x 1 dose |
|
| Placebo | Drug | Dextrose 5% in water IV x 1 dose |
|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |