WithdrawnPhase 1

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

Stopped: The study had been cancelled and replaced with protocol 20130250.

0Started 2011-06

Plain-language 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.

Who can participate

Age range

12 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT01395485

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-06

View on ClinicalTrials.gov More Asthma trials

Who can participate

Age range

12 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.