Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma
Phase 1
Withdrawn
- Conditions
- Asthma
- Interventions
- Drug: AMG 827 or Placebo
- Registration Number
- NCT01395485
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 AMG 827 or Placebo Adolescents - Ages 13 to \<17 Cohort 1 AMG 827 or Placebo Adolescents - Ages 12 to \<13 Cohort 4 AMG 827 or Placebo Adults - Ages 18 to \<=50 Cohort 3 AMG 827 or Placebo Adolescents - Ages 17 to \<18
- Primary Outcome Measures
Name Time Method 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 Participants will be followed for the duration of the study, an expected average of 5 weeks
- Secondary Outcome Measures
Name Time Method 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 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 Intermittantly throughout the duration of the study, an expected average of 5 weeks