A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects
NCT01695876 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2015-03-04
Summary
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects
Conditions
- Inflammatory Disease
Interventions
- DRUG
-
AMG 357
Oral administration available in varying dose strength.
- DRUG
-
Matching placebo to AMG 357 containing no active drug
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 25 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2014-09-30
- Completion
- 2014-10-31
Countries
- New Zealand
Study Locations
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