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This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception and sedation in healthy adult males.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRV130A | Experimental |
| |
| Dextrose in Water | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRV130A | Drug | Intravenous infusion of 1 hour duration |
| |
| Dextrose in Water |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | Baseline to 8 days after dose administration | |
| Area under the plasma concentration versus time curve of TRV130A | Baseline to 24 hours after dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of TRV130A on pain perception using cold pain test | Baseline to 3 hours after dose administration | |
| Effect of TRV130A on pupil diameter | Baseline to 3 hours after dose administration | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David G. Soergel, MD | Trevena Inc. | Study Director |
| Alan S. Marion, MD, PhD | ICON Development Solutions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Development Solutions | Omaha | Nebraska | 68154 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24122908 | Derived | Soergel DG, Subach RA, Sadler B, Connell J, Marion AS, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV130: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2014 Mar;54(3):351-7. doi: 10.1002/jcph.207. Epub 2014 Jan 28. | |
| 23813302 | Derived | Soergel DG, Subach RA, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV027: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2013 Sep;53(9):892-9. doi: 10.1002/jcph.111. Epub 2013 Jun 29. |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D014867 | Water |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D006878 |
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| Drug |
Intravenous infusion of 1 hour duration |
|
| Effect of TRV130A on eye movements |
Using saccadic eye movement measurement |
| Baseline to 3 hours after dose administration |
| Effect of TRV130A on sedation | Sedation evaluated by questionnaire | Baseline to 3 hours after dose administration |
| Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |