A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects
NCT ID: NCT01695876
Last Updated: 2015-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
58 participants
INTERVENTIONAL
2012-10-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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AMG 357
AMG 357 is a small molecule for treatment of inflammatory disease
AMG 357
Oral administration available in varying dose strength.
Placebo
Matching placebo to AMG 357 containing no active drug
Placebo
Matching placebo to AMG 357 containing no active drug
Interventions
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AMG 357
Oral administration available in varying dose strength.
Placebo
Matching placebo to AMG 357 containing no active drug
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 18 and 32 kg/m2
* Normal or clinically acceptable physical examination, clinical laboratory values, and ECG
Exclusion Criteria
25 Years
55 Years
ALL
Yes
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Christchurch, , New Zealand
Christchurch, , New Zealand
Research Site
Grafton, Auckland, , New Zealand
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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Inflammation
Identifier Type: OTHER
Identifier Source: secondary_id
20110246
Identifier Type: -
Identifier Source: org_study_id
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