Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma

November 20, 2013 updated by: Amgen

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescent (12 to <18 Years) and Adult Subjects With Intermittent or Mild to Moderate Persistent Asthma

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

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

12 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and/or female subjects 12 to < 18 years of age at the time of randomization
  • Male and/or female subjects between 18 and 50 years of age (inclusive) at the time of randomization
  • Body weight ≥ 36 kg at screening
  • Intermittent or mild to moderate persistent asthma for at least the past 3 months prior to study enrollment (as defined by the 2004 Global Initiative for Asthma [GINA] guidelines.

Exclusion Criteria:

  • Experienced an asthma exacerbation (defined as a disease episode resulting in treatment in an emergency room or urgent care facility, or an episode treated with oral corticosteroids) during the 3 months prior to study enrollment.
  • Hospitalized for asthma during the 6 months prior to study enrollment; or ever intubated for the treatment of asthma.
  • Use of oral corticosteroids within 3 months prior to study enrollment.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 2
Adolescents - Ages 13 to <17
Drug: AMG 827 or Placebo
A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).
Experimental: Cohort 1
Adolescents - Ages 12 to <13
Drug: AMG 827 or Placebo
A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).
Experimental: Cohort 4
Adults - Ages 18 to <=50
Drug: AMG 827 or Placebo
A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).
Experimental: Cohort 3
Adolescents - Ages 17 to <18
Drug: AMG 827 or Placebo
A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adolescent subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability
Time Frame: Participants will be followed for the duration of the study, an expected average of 5 weeks
Participants will be followed for the duration of the study, an expected average of 5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the AMG 827 concentration versus time curve (AUC) for times 0 to infinity (AUC 0-inf) and 0 to last sampling time point (AUC 0-tlast), peak plasma concentration (Cmax) and Time to peak plasma concentration (tmax) will be determined for AMG 827
Time Frame: Intermittantly throughout the duration of the study, an expected average of 5 weeks
Intermittantly throughout the duration of the study, an expected average of 5 weeks
Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adult subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability
Time Frame: Intermittantly throughout the duration of the study, an expected average of 5 weeks
Intermittantly throughout the duration of the study, an expected average of 5 weeks

Collaborators and Investigators

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

Sponsor

Amgen

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.

Helpful Links

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

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

May 5, 2011

First Submitted That Met QC Criteria

July 14, 2011

First Posted (Estimate)

July 15, 2011

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 20, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20101281

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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