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

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ClinicalTrials.gov Identifier: NCT02083315
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
Trevena Inc.

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

Condition or disease Intervention/treatment Phase
Pain, Acute Drug: TRV130 1.5 mg Drug: TRV130 3 mg Drug: TRV130 4.5 mg Drug: Morphine 10 mg Drug: Placebo Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TRV130 1.5 mg
TRV130 1.5 mg IV x 1 dose
Drug: TRV130 1.5 mg
TRV130 1.5 mg IV x 1 dose

Experimental: TRV130 3 mg
TRV130 3 mg IV x 1 dose
Drug: TRV130 3 mg
TRV130 3 mg IV x 1 dose

Experimental: TRV130 4.5 mg
TRV130 4.5 mg IV x 1 dose
Drug: TRV130 4.5 mg
TRV130 4.5 mg IV x 1 dose

Active Comparator: Morphine
Morphine 10 mg IV x 1 dose
Drug: Morphine 10 mg
Morphine 10 mg IV x 1 dose

Placebo Comparator: Placebo
Dextrose 5% in water IV x 1 dose
Drug: Placebo
Dextrose 5% in water IV x 1 dose




Primary Outcome Measures :
  1. Cold Pain Test [ Time Frame: 8 hours postdose ]

Secondary Outcome Measures :
  1. Ventilatory Response to Hypercapnia [ Time Frame: 4 hours postdose ]
  2. Pupillometry [ Time Frame: 8 hours postdose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083315


Locations
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United States, Utah
CRI Lifetree
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Trevena Inc.
Investigators
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Study Chair: David G Soergel, MD Trevena Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Trevena Inc.
ClinicalTrials.gov Identifier: NCT02083315    
Other Study ID Numbers: CP130-1003
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014
Keywords provided by Trevena Inc.:
acute pain, analgesia, respiratory drive, ventilator response to hypercapnia, pupillometry
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents