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

March 2, 2015 updated by: Amgen
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Christchurch, New Zealand
      • Christchurch, New Zealand, 8011
        • Research Site
      • Grafton, Auckland, New Zealand, 1010
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AMG 357
AMG 357 is a small molecule for treatment of inflammatory disease
Oral administration available in varying dose strength.
PLACEBO_COMPARATOR: Placebo
Matching placebo to AMG 357 containing no active drug
Matching placebo to AMG 357 containing no active drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 35 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 35 days
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
up to 11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

September 26, 2012

First Submitted That Met QC Criteria

September 26, 2012

First Posted (ESTIMATE)

September 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 20110246
  • Inflammation (OTHER: Amgen)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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