Back to resultsPharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Subjects
Primary Purpose
Pain, Acute
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TRV130 1.5 mg
TRV130 3 mg
TRV130 4.5 mg
Morphine 10 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Acute focused on measuring acute pain, analgesia, respiratory drive, ventilator response to hypercapnia, pupillometry
Eligibility Criteria
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
Sites / Locations
- CRI Lifetree
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
TRV130 1.5 mg
TRV130 3 mg
TRV130 4.5 mg
Morphine
Placebo
Arm Description
TRV130 1.5 mg IV x 1 dose
TRV130 3 mg IV x 1 dose
TRV130 4.5 mg IV x 1 dose
Morphine 10 mg IV x 1 dose
Dextrose 5% in water IV x 1 dose
Outcomes
Primary Outcome Measures
Cold Pain Test
Secondary Outcome Measures
Ventilatory Response to Hypercapnia
Pupillometry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02083315
Brief Title
Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Subjects
Official Title
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
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trevena Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
acute pain, analgesia, respiratory drive, ventilator response to hypercapnia, pupillometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRV130 1.5 mg
Arm Type
Experimental
Arm Description
TRV130 1.5 mg IV x 1 dose
Arm Title
TRV130 3 mg
Arm Type
Experimental
Arm Description
TRV130 3 mg IV x 1 dose
Arm Title
TRV130 4.5 mg
Arm Type
Experimental
Arm Description
TRV130 4.5 mg IV x 1 dose
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Morphine 10 mg IV x 1 dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dextrose 5% in water IV x 1 dose
Intervention Type
Drug
Intervention Name(s)
TRV130 1.5 mg
Intervention Description
TRV130 1.5 mg IV x 1 dose
Intervention Type
Drug
Intervention Name(s)
TRV130 3 mg
Intervention Description
TRV130 3 mg IV x 1 dose
Intervention Type
Drug
Intervention Name(s)
TRV130 4.5 mg
Intervention Description
TRV130 4.5 mg IV x 1 dose
Intervention Type
Drug
Intervention Name(s)
Morphine 10 mg
Intervention Description
Morphine 10 mg IV x 1 dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dextrose 5% in water IV x 1 dose
Primary Outcome Measure Information:
Title
Cold Pain Test
Time Frame
8 hours postdose
Secondary Outcome Measure Information:
Title
Ventilatory Response to Hypercapnia
Time Frame
4 hours postdose
Title
Pupillometry
Time Frame
8 hours postdose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Soergel, MD
Organizational Affiliation
Trevena Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
CRI Lifetree
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24954166
Citation
Soergel DG, Subach RA, Burnham N, Lark MW, James IE, Sadler BM, Skobieranda F, Violin JD, Webster LR. Biased agonism of the mu-opioid receptor by TRV130 increases analgesia and reduces on-target adverse effects versus morphine: A randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Pain. 2014 Sep;155(9):1829-1835. doi: 10.1016/j.pain.2014.06.011. Epub 2014 Jun 19.
Results Reference
derived
Learn more about this trial
Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Subjects
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