Inflammatory DiseasePhase 1NCT01695876
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects
A Phase 1 study testing AMG 357 in people with Inflammatory Disease, run by Amgen at 3 sites in New Zealand.
Trial summary
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Disease
- What is being tested?
- AMG 357
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 3 sitesNew Zealand
- Study dates
- Oct 2012to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Any history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety.
- Additional exclusion criteria apply
Trial locations and contacts
3 sites in 1 country.
New Zealand3 sites
Research Site
Christchurch, 8011
Study site
Christchurch
Research Site
Grafton, Auckland, 1010
About this study
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects
- Conditions
- Inflammatory Disease
- Being tested
- AMG 357, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 357Drug
Oral administration available in varying dose strength.
PlaceboDrug
Matching placebo to AMG 357 containing no active drug
| Study group | Role | What they receive |
|---|---|---|
| AMG 357 | Experimental | AMG 357 is a small molecule for treatment of inflammatory disease Receives: Drug: AMG 357 |
| Placebo | Placebo comparator | Matching placebo to AMG 357 containing no active drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 35 days
Secondary outcomes (2)
Pharmacodynamics
Measure the area under the plasma concentration curve versus time of AMG 357 after single and multiple dose administration in healthy subjects
Measured: up to 35 days
Effect of Food on AMG 357
To assess the effect of food on the PK parameters of AMG 357
Measured: up to 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695876
- Sponsor's protocol ID
- 20110246
- Other IDs
- Inflammation
- Status last verified
- Jan 2015
- First submitted
- 26 Sep 2012
- Last updated
- 4 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01695876
- Acronym / sponsor ID
- 20110246
- Conditions
- Inflammatory Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 357 | Experimental | Drug: AMG 357AMG 357 is a small molecule for treatment of inflammatory disease |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo to AMG 357 containing no active drug |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Any history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety.
- Additional exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 357Oral administration available in varying dose strength. | Drug | AMG 357 |
| PlaceboMatching placebo to AMG 357 containing no active drug | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Pharmacodynamics
Time frame: up to 35 days
Effect of Food on AMG 357
Time frame: up to 11 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 357 in people with Inflammatory Disease, run by Amgen at 3 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: up to 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2015.