Pain, Acute
Conditions
Keywords
acute pain, analgesia, respiratory drive, ventilator response to hypercapnia, pupillometry
Brief summary
This study is designed to compare TRV130 to placebo and morphine to learn about its effects on pain relief and side effects.
Detailed description
This study will explore the pharmacokinetics, pharmacodynamics (PD), safety and tolerability of TRV130.
Interventions
DRUGTRV130 1.5 mg
TRV130 1.5 mg IV x 1 dose
DRUGTRV130 3 mg
TRV130 3 mg IV x 1 dose
DRUGTRV130 4.5 mg
TRV130 4.5 mg IV x 1 dose
DRUGMorphine 10 mg
Morphine 10 mg IV x 1 dose
DRUGPlacebo
Dextrose 5% in water IV x 1 dose
Sponsors
Trevena Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed consent * Healthy adult males age 18 - 50 years, BMI 19-32 kg/m2 * Acceptable duration of cold pain test results at screening
Exclusion criteria
* Clinically significant medical illness or physical exam findings * Active dermatological conditions or skin trauma on the non-dominant hand, or peripheral vascular disease * Partial blindness, keratoconus, nystagmus or any other ophthalmic condition which could interfere with pupillometry * Use of tobacco or nicotine within 6 months prior to screening * History of recent (within 6 months) drug or alcohol abuse, as defined in DSM-IV-TR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cold Pain Test | 8 hours postdose |
Secondary
| Measure | Time frame |
|---|---|
| Ventilatory Response to Hypercapnia | 4 hours postdose |
| Pupillometry | 8 hours postdose |
Countries
United States
Outcome results
None listed