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

Trevena

Status and phase: Completed; Phase 1

Conditions: Pain, Acute

Treatments: Drug: TRV130 1.5 mg; Drug: Placebo; Drug: TRV130 4.5 mg; Drug: Morphine 10 mg; Drug: TRV130 3 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02083315

CP130-1003

Details and patient eligibility

About

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

Full description

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

Enrollment: 30 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 5 patient groups, including a placebo group

TRV130 1.5 mg

Experimental group

Description:

TRV130 1.5 mg IV x 1 dose

Treatment:

Drug: TRV130 1.5 mg

TRV130 3 mg

Experimental group

Description:

TRV130 3 mg IV x 1 dose

Treatment:

Drug: TRV130 3 mg

TRV130 4.5 mg

Experimental group

Description:

TRV130 4.5 mg IV x 1 dose

Treatment:

Drug: TRV130 4.5 mg

Morphine

Active Comparator group

Description:

Morphine 10 mg IV x 1 dose

Treatment:

Drug: Morphine 10 mg

Placebo

Placebo Comparator group

Description:

Dextrose 5% in water IV x 1 dose

Treatment:

Drug: Placebo