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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01395485
• Other study ID #: 20101281
• Status: Withdrawn
• Phase: Phase 1
• First received: May 5, 2011
• Last updated: November 20, 2013
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: November 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AMG 827 or Placebo
A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	Yes

External Links

•   AmgenTrials clinical trials website