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

NCT01395485 | Withdrawn Phase 1

• 1 other identifier: 20101281
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

Amgen; Adolescent; Single Dose; Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (4)

Cohort 2

EXPERIMENTAL

Adolescents - Ages 13 to \<17

Drug: AMG 827 or Placebo

Cohort 1

EXPERIMENTAL

Adolescents - Ages 12 to \<13

Drug: AMG 827 or Placebo

Cohort 4

EXPERIMENTAL

Adults - Ages 18 to \<=50

Drug: AMG 827 or Placebo

Cohort 3

EXPERIMENTAL

Adolescents - Ages 17 to \<18

Drug: AMG 827 or Placebo

Interventions

AMG 827 or Placebo DRUG

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

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Asthma

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: July 15, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 25, 2013

Record last verified: 2013-11