Chronic Pain
Conditions
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.
Interventions
DRUGAMG 403
AMG 403 is for treatment of subjects with chronic pain
DRUGPlacebo
contains no active drug
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events | up to 112 days | — |
| Incidence of abnormal clinically significant vital signs | 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. |
| Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results | 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. |
| Incidence of abnormal clinically significant ECG results | 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
| Measure | Time frame |
|---|---|
| Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax | up to 112 days |
Outcome results
None listed