Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Subjects
Phase 1
Completed
- Conditions
- Pain, Acute
- Interventions
- Registration Number
- NCT02083315
- Lead Sponsor
- Trevena Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TRV130 1.5 mg TRV130 1.5 mg TRV130 1.5 mg IV x 1 dose TRV130 3 mg TRV130 3 mg TRV130 3 mg IV x 1 dose TRV130 4.5 mg TRV130 4.5 mg TRV130 4.5 mg IV x 1 dose Morphine Morphine 10 mg Morphine 10 mg IV x 1 dose Placebo Placebo Dextrose 5% in water IV x 1 dose
- Primary Outcome Measures
Name Time Method Cold Pain Test 8 hours postdose
- Secondary Outcome Measures
Name Time Method Ventilatory Response to Hypercapnia 4 hours postdose Pupillometry 8 hours postdose
Trial Locations
- Locations (1)
CRI Lifetree
🇺🇸Salt Lake City, Utah, United States
CRI Lifetree🇺🇸Salt Lake City, Utah, United States