Inflammatory Disease
Conditions
Brief summary
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects
Interventions
DRUGAMG 357
Oral administration available in varying dose strength.
DRUGPlacebo
Matching placebo to AMG 357 containing no active drug
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics | 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 |
| Effect of Food on AMG 357 | up to 11 days | To assess the effect of food on the PK parameters of AMG 357 |
Countries
New Zealand
Outcome results
None listed