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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01695876
First received: September 26, 2012
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Inflammatory Disease
Drug: AMG 357
Drug: Placebo
Phase 1

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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: up to 35 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Pharmacodynamics [ Time Frame: up to 35 days ] [ Designated as safety issue: Yes ]
    Measure the area under the plasma concentration curve versus time of AMG 357 after single and multiple dose administration in healthy subjects

  • Effect of Food on AMG 357 [ Time Frame: up to 11 days ] [ Designated as safety issue: No ]
    To assess the effect of food on the PK parameters of AMG 357


Estimated Enrollment: 58
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 357
AMG 357 is a small molecule for treatment of inflammatory disease
Drug: AMG 357
Oral administration available in varying dose strength.
Placebo Comparator: Placebo
Matching placebo to AMG 357 containing no active drug
Drug: Placebo
Matching placebo to AMG 357 containing no active drug

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695876

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
New Zealand
Not yet recruiting
Christchurch, New Zealand
Research Site Recruiting
Christchurch, New Zealand, 8011
Research Site Recruiting
Grafton, Auckland, New Zealand, 1010
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01695876     History of Changes
Other Study ID Numbers: 20110246, Inflammation
Study First Received: September 26, 2012
Last Updated: July 31, 2014
Health Authority: New Zealand: Medsafe

ClinicalTrials.gov processed this record on August 20, 2014