Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Subjects

Study Overview
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Brief Summary
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This study is designed to compare TRV130 to placebo and morphine to learn about its effects on pain relief and side effects.

Detailed Description
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This study will explore the pharmacokinetics, pharmacodynamics (PD), safety and tolerability of TRV130.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Explore the Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Adult Male Subjects

Conditions
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Pain, Acute

Intervention / Treatment
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* Drug: TRV130 1.5 mg
* Drug: TRV130 3 mg
* Drug: TRV130 4.5 mg
* Drug: Morphine 10 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRV130 1.5 mg<br>TRV130 1.5 mg IV x 1 dose | Drug: TRV130 1.5 mg<br>* TRV130 1.5 mg IV x 1 dose<br>|
| Experimental: TRV130 3 mg<br>TRV130 3 mg IV x 1 dose | Drug: TRV130 3 mg<br>* TRV130 3 mg IV x 1 dose<br>|
| Experimental: TRV130 4.5 mg<br>TRV130 4.5 mg IV x 1 dose | Drug: TRV130 4.5 mg<br>* TRV130 4.5 mg IV x 1 dose<br>|
| Active Comparator: Morphine<br>Morphine 10 mg IV x 1 dose | Drug: Morphine 10 mg<br>* Morphine 10 mg IV x 1 dose<br>|
| Placebo Comparator: Placebo<br>Dextrose 5% in water IV x 1 dose | Drug: Placebo<br>* Dextrose 5% in water IV x 1 dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cold Pain Test |  | 8 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilatory Response to Hypercapnia |  | 4 hours postdose | 
| Pupillometry |  | 8 hours postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pain, analgesia, respiratory drive, ventilator response to hypercapnia, pupillometry