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

NCT ID: NCT01395485

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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Amgen Adolescent Single Dose Safety Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cohort 2

Adolescents - Ages 13 to \<17

Group Type EXPERIMENTAL

AMG 827 or Placebo

Intervention Type DRUG

A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).

Cohort 1

Adolescents - Ages 12 to \<13

Group Type EXPERIMENTAL

AMG 827 or Placebo

Intervention Type DRUG

A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).

Cohort 4

Adults - Ages 18 to \<=50

Group Type EXPERIMENTAL

AMG 827 or Placebo

Intervention Type DRUG

A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).

Cohort 3

Adolescents - Ages 17 to \<18

Group Type EXPERIMENTAL

AMG 827 or Placebo

Intervention Type DRUG

A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).

Interventions

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AMG 827 or Placebo

A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20101281

Identifier Type: -

Identifier Source: org_study_id