A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects
- Registration Number
- NCT01695876
- Lead Sponsor
- Amgen
- Brief Summary
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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 exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description AMG 357 AMG 357 AMG 357 is a small molecule for treatment of inflammatory disease Placebo Placebo Matching placebo to AMG 357 containing no active drug
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Effect of Food on AMG 357 up to 11 days To assess the effect of food on the PK parameters of AMG 357
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
Trial Locations
- Locations (1)
Research Site
🇳🇿Grafton, Auckland, New Zealand