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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348879
• Other study ID #: 20040195
• Status: Completed
• Phase: Phase 1
• First received: December 23, 2014
• Last updated: January 28, 2015
• Start date: January 2005
• Est. completion date: March 2006

Study information

• Verified date: January 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• AMG 403
AMG 403 is for treatment of subjects with chronic pain
• Placebo
contains no active drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events		up to 112 days	Yes
Primary	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.	up to 112 days	Yes
Primary	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.	up to 112 days	Yes
Primary	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.	up to 112 days	Yes
Secondary	Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax		up to 112 days	No

External Links

•   AmgenTrials clinical trials website