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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Scientific title
Secondary ID [1] 0 0
Inflammation
Secondary ID [2] 0 0
20110246
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability - 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.
Timepoint [1] 0 0
up to 35 days
Secondary outcome [1] 0 0
Pharmacodynamics - Measure the area under the plasma concentration curve versus time of AMG 357 after single and multiple dose administration in healthy subjects
Timepoint [1] 0 0
up to 35 days
Secondary outcome [2] 0 0
Effect of Food on AMG 357 - To assess the effect of food on the PK parameters of AMG 357
Timepoint [2] 0 0
up to 11 days

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
Minimum age
25 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Grafton, Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy
subjects
Trial website
https://clinicaltrials.gov/show/NCT01695876
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications