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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01395485
First received: May 5, 2011
Last updated: November 20, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395485

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

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01395485     History of Changes
Other Study ID Numbers: 20101281
Study First Received: May 5, 2011
Last Updated: November 20, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014