Back to resultsSafety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma
Primary Purpose
Asthma
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AMG 827 or Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Asthma focused on measuring Amgen, Adolescent, Single Dose, Safety, Pharmacokinetics
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 2
Cohort 1
Cohort 4
Cohort 3
Arm Description
Adolescents - Ages 13 to <17
Adolescents - Ages 12 to <13
Adults - Ages 18 to <=50
Adolescents - Ages 17 to <18
Outcomes
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01395485
Brief Title
Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Withdrawn
Why Stopped
The study had been cancelled and replaced with protocol 20130250.
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Amgen, Adolescent, Single Dose, Safety, Pharmacokinetics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Adolescents - Ages 13 to <17
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Adolescents - Ages 12 to <13
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Adults - Ages 18 to <=50
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Adolescents - Ages 17 to <18
Intervention Type
Drug
Intervention Name(s)
AMG 827 or Placebo
Intervention Description
A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma
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