Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Subjects
Overview
This study is designed to compare TRV130 to placebo and morphine to learn about its effects on pain relief and side effects.
Full Title of Study: “A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Explore the Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Adult Male Subjects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: August 2013
Detailed Description
This study will explore the pharmacokinetics, pharmacodynamics (PD), safety and tolerability of TRV130.
Interventions
- Drug: TRV130 1.5 mg
- TRV130 1.5 mg IV x 1 dose
- Drug: TRV130 3 mg
- TRV130 3 mg IV x 1 dose
- Drug: TRV130 4.5 mg
- TRV130 4.5 mg IV x 1 dose
- Drug: Morphine 10 mg
- Morphine 10 mg IV x 1 dose
- Drug: Placebo
- Dextrose 5% in water IV x 1 dose
Arms, Groups and Cohorts
- Experimental: TRV130 1.5 mg
- TRV130 1.5 mg IV x 1 dose
- Experimental: TRV130 3 mg
- TRV130 3 mg IV x 1 dose
- Experimental: TRV130 4.5 mg
- TRV130 4.5 mg IV x 1 dose
- Active Comparator: Morphine
- Morphine 10 mg IV x 1 dose
- Placebo Comparator: Placebo
- Dextrose 5% in water IV x 1 dose
Clinical Trial Outcome Measures
Primary Measures
- Cold Pain Test
- Time Frame: 8 hours postdose
Secondary Measures
- Ventilatory Response to Hypercapnia
- Time Frame: 4 hours postdose
- Pupillometry
- Time Frame: 8 hours postdose
Participating in This Clinical Trial
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
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Trevena Inc.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- David G Soergel, MD, Study Chair, Trevena Inc.
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