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

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ClinicalTrials.gov Identifier: NCT02348879
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : January 30, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: AMG 403 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: AMG 403
AMG 403 administered as subcutaneous and intravenous doses
Drug: AMG 403
AMG 403 is for treatment of subjects with chronic pain

Placebo Comparator: Placebo
No active drug
Drug: Placebo
contains no active drug

Primary Outcome Measures :
  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 Outcome Measures :
  1. Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax [ Time Frame: up to 112 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   Yes

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.

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): NCT02348879

Sponsors and Collaborators
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Study Director: MD Amgen
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02348879    
Other Study ID Numbers: 20040195
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations