Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines
A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 333 in Healthy Subjects and Subjects With Migraines.
1 other identifier
interventional
74
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2013
CompletedFirst Posted
Study publicly available on registry
September 30, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedDecember 9, 2014
December 1, 2014
11 months
September 26, 2013
December 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary
Treatment-emergent adverse events, including changes in vital signs, 12-lead ECGs, clinical laboratory safety tests, and physical and neurological assessments
Up to 29 days
Primary
Headache assessment as measured by the occurrence of moderate-to-severe headache within 36 hours of treatment, as well as number of moderate-to-severe headaches within 4 days of dosing
Up to 29 days
Secondary Outcomes (4)
Secondary Outcome Measures
Up to 29 Days
Secondary
Up to 29 days
Secondary Outcome Measures
Up to 29 Days
Secondary Outcome Measures
Up to 29 Days
Study Arms (2)
AMG 333
EXPERIMENTALSubjects will receive a single oral dose of AMG 333 .
Placebo
PLACEBO COMPARATORSubjects will receive a single oral dose of placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and female subjects with or without migraines ≥18 and ≤55 years of age at the time of screening, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician.
You may not qualify if:
- History or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator and Amgen physician, would significantly impair pain perception (eg, history of stroke, history of neuropathy) or interfere with evaluation, procedures, or study completion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (1)
Research Site
Salt Lake City, Utah, 84106, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2013
First Posted
September 30, 2013
Study Start
October 1, 2013
Primary Completion
September 1, 2014
Study Completion
November 1, 2014
Last Updated
December 9, 2014
Record last verified: 2014-12