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

NCT02083315 | Completed Phase 1

• 1 other identifier: CP130-1003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Acute

Keywords

acute pain, analgesia, respiratory drive, ventilator response to hypercapnia, pupillometry

Outcome Measures

Primary Outcomes (1)

• Cold Pain Test

  8 hours postdose

Secondary Outcomes (2)

• Ventilatory Response to Hypercapnia

  4 hours postdose

• Pupillometry

  8 hours postdose

Study Arms (5)

TRV130 1.5 mg

EXPERIMENTAL

TRV130 1.5 mg IV x 1 dose

Drug: TRV130 1.5 mg

TRV130 3 mg

EXPERIMENTAL

TRV130 3 mg IV x 1 dose

Drug: TRV130 3 mg

TRV130 4.5 mg

EXPERIMENTAL

TRV130 4.5 mg IV x 1 dose

Drug: TRV130 4.5 mg

Morphine

ACTIVE COMPARATOR

Morphine 10 mg IV x 1 dose

Drug: Morphine 10 mg

Placebo

PLACEBO COMPARATOR

Dextrose 5% in water IV x 1 dose

Drug: Placebo

Interventions

TRV130 1.5 mg DRUG

TRV130 1.5 mg IV x 1 dose

TRV130 1.5 mg

TRV130 3 mg DRUG

TRV130 3 mg IV x 1 dose

TRV130 3 mg

TRV130 4.5 mg DRUG

TRV130 4.5 mg IV x 1 dose

TRV130 4.5 mg

Morphine 10 mg DRUG

Morphine 10 mg IV x 1 dose

Morphine

Placebo DRUG

Dextrose 5% in water IV x 1 dose

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Trevena Inc.: lead

Study Sites (1)

CRI Lifetree

Salt Lake City, Utah, 84106, United States

Location

Related Publications (1)

• 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.

  PMID: 24954166 DERIVED

MeSH Terms

Conditions

Acute Pain; Agnosia

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• David G Soergel, MD

  Trevena Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: March 11, 2014
• Study Start: July 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 11, 2014

Record last verified: 2014-03

Locations

US (1)