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Study Complete
Sponsor ID
20040195

A study to examine the safety, pharmacokinetics and pharmacodynamics of AMG 403 in healthy subject

Sponsor ID
20040195
Clinicaltrials.gov ID
NCT02348879
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 403
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
51
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of treatment emergent adverse events

Timeframe: up to 112 days

Incidence of abnormal clinically significant vital signs

Timeframe: up to 112 days

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

Timeframe: up to 112 days

Incidence of abnormal clinically significant ECG results

Timeframe: up to 112 days

Secondary Outcome Measures

Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax

Timeframe: up to 112 days

Locations

No locations found.
Study Info
Age
N/A
Condition
  • Pain
    • Sex
    N/A
    Trial Dates
    Jan 2005 - Jan 2006
    Inclusion and Exclusion Criteria
    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.