A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 853 in Adolescent (≥ 12 to <18 Years) and Adult Subjects With Intermittent or Mild to Moderate Persistent Asthma

Amgen0 sites23 target enrollmentJune 2010

ConditionsAsthma

InterventionsAMG 853 Placebo

Overview

Phase: Phase 1
Intervention: AMG 853
Conditions: Asthma
Sponsor: Amgen
Enrollment: 23
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: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to study the safety and tolerability in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

January 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and/or female subjects ≥12 to \< 18 years of age (for Cohorts 1, 2, and 3 as indicated in the study design).
•Male and/or non-reproductive female subjects between 18 and 50 years of age, inclusive (for cohort 4).
•Females of non-reproductive potential must have documented medical history (ie, postmenopausal by history - no menses for 1 year - and follicle-stimulating hormone value (FSH) consistent with postmenopausal status per laboratory ranges; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
•Females of child-bearing potential and females who cannot document non-reproductive potential must agree to use highly effective methods of birth control for the duration of the study and for 2 weeks after study drug administration. Males whose partners are of child bearing potential must agree to use highly effective methods of birth control for the duration of the study and continuing for 12 weeks after study drug administration. Highly effective methods of birth control (i.e., those with a failure rate of less than 1% per year) include sexual abstinence (males, females), vasectomy or a condom supplemented with the use of a spermicide (males) and occlusive cap (diaphragm or cervical/vault caps), hormonal birth control, or intrauterine device (IUD) used by the female partner.
•Male subjects whose partners become pregnant during the study must practice sexual abstinence or use a condom with spermicide for two weeks following study drug administration to ensure the unborn child is not potentially exposed to AMG 853 via semen. The pregnant partner information will be reported to Amgen per the Pregnancy Notification Worksheet.
•Intermittent or mild to moderate persistent asthma for the past 3 months (as defined by the 2004 Global Initiative for Asthma \[GINA\] guidelines).
•On a stable pharmacologic regimen for the treatment of asthma for at least 3 months prior to study enrollment and does not anticipate any change to the regimen during the course of the study.
•Forced Expiry Volume in 1 second (FEV1) at screening visit ≥ 70% of predicted normal value (without aid of bronchodilator).
•FEV1 reversibility greater than or equal to 12% from baseline within 30 minutes of inhaled (up to 400 μg) or nebulized (up to 5 mg) albuterol at the office screening visit. Subjects unable to demonstrate reversibility during screening, must provide the most recent evidence of documented reversibility to the Amgen Medical Monitor and the principal investigator for review.
•Clinically acceptable physical examination, electrocardiogram (ECG), and clinical laboratory test values for the population tested. Any abnormal clinical laboratory results and/or ECG values must be discussed with the Sponsor.

Exclusion Criteria

•History or evidence of clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
•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.
•Evidence of recent (within 2 weeks of study enrollment) or current signs or symptoms of an upper respiratory infection (eg, viral, bacterial).
•Known positive tuberculin skin test (if not treated with appropriate chemoprophylaxis) or untreated exposure to a patient with active tuberculosis.
•History of autoimmune disorder (eg, rheumatoid arthritis, systemic lupus).
•Creatinine clearance within the screening period of less than 80 mL/min as calculated by the Cockcroft-Gault method.
•History of clinically significant cardiovascular, renal, hepatic or respiratory disease other than asthma.
•History suggestive of esophageal, gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or irritable bowel syndrome), or a history of gastrointestinal surgery (excluding uncomplicated appendectomy).

Arms & Interventions

AMG 853

Intervention: AMG 853

Placebo

Intervention: 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: Throughout the study duration

Secondary Outcomes

Pharmacokinetic parameters (including Cmax and AUC) for a single dose administration of AMG 853 in adolescent and adult subjects(Throughout study duration (at predose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 168 hours after dose))