AsthmaPhase 1NCT01395485
Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma
A Phase 1 study of Asthma, run by Amgen.
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. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Asthma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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
- Being tested
- AMG 827 or Placebo
- Keywords
- Amgen, Adolescent, Single Dose, Safety, Pharmacokinetics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 827 or PlaceboDrug
A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2 | Experimental | Adolescents - Ages 13 to <17 Receives: Drug: AMG 827 or Placebo |
| Cohort 1 | Experimental | Adolescents - Ages 12 to <13 Receives: Drug: AMG 827 or Placebo |
| Cohort 4 | Experimental | Adults - Ages 18 to <=50 Receives: Drug: AMG 827 or Placebo |
| Cohort 3 | Experimental | Adolescents - Ages 17 to <18 Receives: Drug: AMG 827 or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Intermittantly throughout the duration of the study, an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: The study had been cancelled and replaced with protocol 20130250.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395485
- Sponsor's protocol ID
- 20101281
- Status last verified
- Nov 2013
- First submitted
- 5 May 2011
- Last updated
- 25 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01395485
- Acronym / sponsor ID
- 20101281
- Conditions
- Asthma
- Keywords
- Amgen, Adolescent, Single Dose, Safety, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study had been cancelled and replaced with protocol 20130250.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 2 | Experimental | Drug: AMG 827 or PlaceboAdolescents - Ages 13 to <17 |
| Cohort 1 | Experimental | Drug: AMG 827 or PlaceboAdolescents - Ages 12 to <13 |
| Cohort 4 | Experimental | Drug: AMG 827 or PlaceboAdults - Ages 18 to <=50 |
| Cohort 3 | Experimental | Drug: AMG 827 or PlaceboAdolescents - Ages 17 to <18 |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 827 or PlaceboA single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC). | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
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: Participants will be followed for the duration of the study, an expected average of 5 weeks
2 secondary outcomes
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
Time frame: 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
Time frame: Intermittantly throughout the duration of the study, an expected average of 5 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Asthma, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: Participants will be followed for the duration of the study, an expected average of 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.