NCT01395485
Withdrawn
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- AMG 827 or Placebo
- Conditions
- Asthma
- Sponsor
- Amgen
- Primary Endpoint
- 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
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Cohort 2
Adolescents - Ages 13 to \<17
Intervention: AMG 827 or Placebo
Cohort 1
Adolescents - Ages 12 to \<13
Intervention: AMG 827 or Placebo
Cohort 4
Adults - Ages 18 to \<=50
Intervention: AMG 827 or Placebo
Cohort 3
Adolescents - Ages 17 to \<18
Intervention: AMG 827 or Placebo
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Similar Trials
Completed
Phase 1
Safety, Tolerability, and Pharcodynamics of AMG 853 in Adolescents With AsthmaAsthmaNCT01137565Amgen23
Completed
Phase 3
Seasonal Allergic Rhinitis In Pediatric SubjectsRhinitis, Allergic, PerennialNCT00107757GlaxoSmithKline576
Completed
Phase 1
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly CohortAlzheimer's DiseaseNCT01294540Eisai Inc.73
Completed
Phase 1
A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy SubjectsThrombosisNCT03197779Bristol-Myers Squibb691
Completed
Phase 1
Phase 1 TAK-906 Single and Multiple Ascending Dose Study in Japanese Healthy Male ParticipantsJapanese Healthy Adult Male ParticipantsNCT03237156Takeda24