A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects

Inflammatory Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695876
• Other study ID #: 20110246
• Secondary ID: Inflammation
• Status: Completed
• Phase: Phase 1
• First received: September 26, 2012
• Last updated: March 2, 2015
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Medsafe
• Study type: Interventional

Clinical Trial Summary

Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy Adult subjects between 25 and 55 years old

• Body mass index (BMI) between 18 and 32 kg/m2

• Normal or clinically acceptable physical examination, clinical laboratory values, and ECG

• Additional inclusion criteria apply

Exclusion Criteria:

• Any history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety.

• Additional exclusion criteria apply

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Disease

Intervention

Drug:
• AMG 357
Oral administration available in varying dose strength.
• Placebo
Matching placebo to AMG 357 containing no active drug

Locations

Country	Name	City	State
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Grafton, Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Examine the number of adverse events per subject, and subject incidence of clinically significant changes in physical examinations, vital signs, laboratory safety tests and electrocardiograms, after single and multiple dose administration of AMG 357 in healthy subjects.	up to 35 days	Yes
Secondary	Pharmacodynamics	Measure the area under the plasma concentration curve versus time of AMG 357 after single and multiple dose administration in healthy subjects	up to 35 days	Yes
Secondary	Effect of Food on AMG 357	To assess the effect of food on the PK parameters of AMG 357	up to 11 days	No

External Links

•   AmgenTrials clinical trials website