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NCT01953341 · ClinicalTrials.gov registry record · Phase 1
Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT01953341: Completed Phase 1 study, sponsored by Amgen.
NCT01953341 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01953341, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine whether AMG 333 is safe and well tolerated in healthy subjects and subjects with migraines. As part of the secondary objectives, this study will characterize the pharmacokinetic (PK) profile of AMG 333, as well as characterize the effect of AMG 333 on the cold pressor test (CPT)-induced increase in blood pressure after single oral doses in healthy subjects and subjects with migraines
Primary Outcome
Treatment-emergent adverse events, including changes in vital signs, 12-lead ECGs, clinical laboratory safety tests, and physical and neurological assessments
Interventions
- DRUG Placebo
- DRUG AMG 333
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT01953341 record still lists
NCT01953341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01953341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01953341 about?
NCT01953341 is a clinical study titled "Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines". The primary purpose of this study is to determine whether AMG 333 is safe and well tolerated in healthy subjects and subjects with migraines. As part of the secondary objectives, this study will characterize the pharmacokinetic (PK) profile of AMG 333, as well as characterize the effect of AMG 333 o...
What is the current status of trial NCT01953341?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2013-10. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01953341?
The interventions under investigation include: Placebo (DRUG), AMG 333 (DRUG).
Who is sponsoring clinical trial NCT01953341?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01953341's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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