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Terminated/Withdrawn
Sponsor ID
20101281

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

Sponsor ID
20101281
Clinicaltrials.gov ID
NCT01395485
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 827
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
0
Additional Study Details

Protocol Summary

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

Timeframe: 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

Timeframe: 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

Timeframe: Intermittantly throughout the duration of the study, an expected average of 5 weeks

Locations

No locations found.
Study Info
Age
12 - 50 Years
Condition
  • Asthma
    • Sex
    All
    Trial Dates
    Jun 2011 - Jun 2012
    Inclusion and Exclusion 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.