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Completed

NCT Number: NCT02348879

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMG 403

Drug

AMG 403 is for treatment of subjects with chronic pain

Placebo

Drug

contains no active drug

Primary outcomes

  1. Incidence of treatment emergent adverse events

    Time frame: up to 112 days

  2. Incidence of abnormal clinically significant vital signs

    Time frame: up to 112 days

    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.

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

    Time frame: up to 112 days

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

  4. Incidence of abnormal clinically significant ECG results

    Time frame: up to 112 days

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

Secondary outcomes

  1. Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax

    Time frame: up to 112 days

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Placebo Controlled, Randomized, Double-blind, Sequential, Rising, Single Dose Study to Examine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous and Subcutaneous AMG 403 in Healthy Young and Older Adult Subjects

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 28, 2015
Registry last updated
Jan 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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