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

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ClinicalTrials.gov Identifier: NCT01695876
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Inflammatory Disease Drug: AMG 357 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2012
Primary Completion Date : September 2014
Study Completion Date : October 2014
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: up to 35 days ]
    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 :
  1. Pharmacodynamics [ Time Frame: up to 35 days ]
    Measure the area under the plasma concentration curve versus time of AMG 357 after single and multiple dose administration in healthy subjects

  2. Effect of Food on AMG 357 [ Time Frame: up to 11 days ]
    To assess the effect of food on the PK parameters of AMG 357


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695876


Locations
New Zealand
Research Site
Christchurch, New Zealand, 8011
Christchurch, New Zealand
Research Site
Grafton, Auckland, New Zealand, 1010
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01695876     History of Changes
Other Study ID Numbers: 20110246
Inflammation ( Other Identifier: Amgen )
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: January 2015