A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 403 in Healthy Subject

Amgen51 enrolled

Overview

This study is to evaluate the safety of AMG 403 in healthy adult subjects. The study consists of a 21 day screening period followed by administration of the investigational product and up to 154 day evaluation period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Pain

Interventions

AMG 403DRUG

AMG 403 is for treatment of subjects with chronic pain

PlaceboDRUG

contains no active drug

Eligibility

Healthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy men and women of non-child bearing potential, * Between the ages of 18 and 55 inclusive, * Body mass index from 18 to 33 kg/m2, * Skin type compatible with the study assessments, and without significant skin allergies, pigmentary disorders, tattoos, or any active dermatologic conditions that might interfere with the study conduct. Exclusion Criteria: * Prior or current history of peripheral neuropathy, paraesthesias, dysesthesias, herpes zoster, post-herpetic neuralgia, * Evidence of any current illness such as a common cold, viral syndrome, or flu-like symptoms, any disturbance of the autonomic nervous system, * History of Raynaud's phenomenon; Know allergy or intolerance to capsaicin or hot peppers.

Outcomes

Primary Outcomes

Incidence of treatment emergent adverse events

Time frame: up to 112 days

Incidence of abnormal clinically significant vital signs

Vital signs to be assessed included temperature, respiratory rate, pulse rate and rhythm (regular/irregular), and blood pressure. Generally, abnormal vital signs were only reported as adverse events if they required treatment or were associated with an adverse event.

Time frame: up to 112 days

Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results

Laboratory abnormalities were defined by laboratory normal ranges and were not reported as adverse events unless symptomatic or associated with an adverse event.

Time frame: up to 112 days

Incidence of abnormal clinically significant ECG results

ECG abnormalities were reported as adverse events if they represented a change from baseline or if associated with symptoms or an adverse event.

Time frame: up to 112 days

Secondary Outcomes

Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax

Time frame: up to 112 days

Data from ClinicalTrials.gov

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