- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01695876
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects
March 2, 2015 updated by: Amgen
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Christchurch, New Zealand
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Christchurch, New Zealand, 8011
- Research Site
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Grafton, Auckland, New Zealand, 1010
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: AMG 357
AMG 357 is a small molecule for treatment of inflammatory disease
|
Oral administration available in varying dose strength.
|
PLACEBO_COMPARATOR: Placebo
Matching placebo to AMG 357 containing no active drug
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Matching placebo to AMG 357 containing no active drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 35 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 35 days
|
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
|
up to 11 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (ACTUAL)
September 1, 2014
Study Completion (ACTUAL)
October 1, 2014
Study Registration Dates
First Submitted
September 26, 2012
First Submitted That Met QC Criteria
September 26, 2012
First Posted (ESTIMATE)
September 28, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
March 4, 2015
Last Update Submitted That Met QC Criteria
March 2, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 20110246
- Inflammation (OTHER: Amgen)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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