Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Subjects
NCT ID: NCT02083315
Last Updated: 2014-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2013-07-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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TRV130 1.5 mg
TRV130 1.5 mg IV x 1 dose
TRV130 1.5 mg
TRV130 1.5 mg IV x 1 dose
TRV130 3 mg
TRV130 3 mg IV x 1 dose
TRV130 3 mg
TRV130 3 mg IV x 1 dose
TRV130 4.5 mg
TRV130 4.5 mg IV x 1 dose
TRV130 4.5 mg
TRV130 4.5 mg IV x 1 dose
Morphine
Morphine 10 mg IV x 1 dose
Morphine 10 mg
Morphine 10 mg IV x 1 dose
Placebo
Dextrose 5% in water IV x 1 dose
Placebo
Dextrose 5% in water IV x 1 dose
Interventions
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TRV130 1.5 mg
TRV130 1.5 mg IV x 1 dose
TRV130 3 mg
TRV130 3 mg IV x 1 dose
TRV130 4.5 mg
TRV130 4.5 mg IV x 1 dose
Morphine 10 mg
Morphine 10 mg IV x 1 dose
Placebo
Dextrose 5% in water IV x 1 dose
Eligibility Criteria
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Inclusion Criteria
* Healthy adult males age 18 - 50 years, BMI 19-32 kg/m2
* Acceptable duration of cold pain test results at screening
Exclusion Criteria
* 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
18 Years
50 Years
MALE
Yes
Sponsors
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Trevena Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David G Soergel, MD
Role: STUDY_CHAIR
Trevena Inc.
Locations
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CRI Lifetree
Salt Lake City, Utah, United States
Countries
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References
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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.
Other Identifiers
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CP130-1003
Identifier Type: -
Identifier Source: org_study_id
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