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Trial · NCT01395485

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

NCT01395485, Phase 1, Withdrawn, Amgen

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma. Trials, record NCT01395485. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01395485

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma
NCT number
NCT01395485
Status
Withdrawn
Phases
Phase 1
Enrollment
0 participants, actual
Lead sponsor
Amgen
Conditions
Asthma
Interventions
AMG 827 or Placebo
First posted
2011-07-15
Last updated
2013-11-25

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryEvaluation 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 tolerabilityParticipants will be followed for the duration of the study, an expected average of 5 weeks
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
SecondaryEvaluation 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 tolerabilityIntermittantly throughout the duration of the study, an expected average of 5 weeks

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01395485

GET https://conductscience.org/api/trials/v1/NCT01395485/registered