Skip to main content
OpenTrials
Completed

NCT Number: NCT01695876

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects

Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammatory Disease

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Christchurch, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 357

Drug

Oral administration available in varying dose strength.

Placebo

Drug

Matching placebo to AMG 357 containing no active drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pharmacodynamics

    Time frame: 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

  2. Effect of Food on AMG 357

    Time frame: up to 11 days

    To assess the effect of food on the PK parameters of AMG 357

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 28, 2012
Registry last updated
Mar 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.