Healthy
Conditions
Keywords
safety, tolerability, TRV130A
Brief summary
This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception and sedation in healthy adult males.
Interventions
DRUGTRV130A
Intravenous infusion of 1 hour duration
Intravenous infusion of 1 hour duration
Sponsors
Trevena Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult male 19 - 50 years of age * Body weight \>/= 50 kg * Capable of giving written informed consent
Exclusion criteria
* Clinically significant disease or conditions that may place the subject at unacceptable risk as a participant in the study, or that may interfere with the safety, tolerability or pharmacodynamic evaluations in the study * Laboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C virus antibody; elevations of aspartate aminotransferase or alanine aminotransferase; positive drug or alcohol test; positive urine test for cotinine * Major surgery within 4 weeks of screening
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Effect of TRV130A on eye movements | Baseline to 3 hours after dose administration | Using saccadic eye movement measurement |
| Effect of TRV130A on sedation | Baseline to 3 hours after dose administration | Sedation evaluated by questionnaire |
Countries
United States
Outcome results
None listed