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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01695876
Registration number
NCT01695876
Ethics application status
Date submitted
26/09/2012
Date registered
28/09/2012
Date last updated
4/03/2015
Titles & IDs
Public title
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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Scientific title
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Secondary ID [1]
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Inflammation
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Secondary ID [2]
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20110246
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Inflammatory Disease
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AMG 357
Treatment: Drugs - Placebo
Experimental: AMG 357 - AMG 357 is a small molecule for treatment of inflammatory disease
Placebo comparator: Placebo - Matching placebo to AMG 357 containing no active drug
Treatment: Drugs: AMG 357
Oral administration available in varying dose strength.
Treatment: Drugs: Placebo
Matching placebo to AMG 357 containing no active drug
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and Tolerability
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Assessment method [1]
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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.
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Timepoint [1]
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up to 35 days
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Secondary outcome [1]
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Pharmacodynamics
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Assessment method [1]
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Measure the area under the plasma concentration curve versus time of AMG 357 after single and multiple dose administration in healthy subjects
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Timepoint [1]
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up to 35 days
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Secondary outcome [2]
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Effect of Food on AMG 357
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Assessment method [2]
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To assess the effect of food on the PK parameters of AMG 357
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Timepoint [2]
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up to 11 days
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Eligibility
Key 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
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Minimum age
25
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2014
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Sample size
Target
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Accrual to date
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Final
58
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Country [2]
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New Zealand
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State/province [2]
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Grafton, Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects
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Trial website
https://clinicaltrials.gov/study/NCT01695876
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01695876
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