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

This study has been withdrawn prior to enrollment.
(The study had been cancelled and replaced with protocol 20130250.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395485
First Posted: July 15, 2011
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  Purpose
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.

Condition Intervention Phase
Asthma Drug: AMG 827 or Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]

Enrollment: 0
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395485


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01395485     History of Changes
Other Study ID Numbers: 20101281
First Submitted: May 5, 2011
First Posted: July 15, 2011
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Amgen:
Amgen
Adolescent
Single Dose
Safety
Pharmacokinetics

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases