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

Completed · Phase 1 · Has a placebo group

Conditions studied: Pain, Acute

In brief

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

Key facts

Study ID

NCT02083315

Run by

Trevena Inc.

People needed

30

Starts

2013-07-01

Expected to finish

2013-08-01

Last updated by the study team

2014-03-11

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Informed consent
• Healthy adult males age 18 - 50 years, BMI 19-32 kg/m2
• Acceptable duration of cold pain test results at screening

You may not qualify if…

• 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

Where it is running

• CRI Lifetree — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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