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Study Complete
Sponsor ID
20101267

Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine Patients

Sponsor ID
20101267
Clinicaltrials.gov ID
NCT01688739
EUCTIS ID
N/A
EudraCT ID
2011-005600-15
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Study Details

The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of erenumab after single subcutaneous (SC) or intravenous (IV) doses in healthy participants and migraine patients as well as to characterize the effect of erenumab on the capsaicin-induced increase in dermal blood flow after single SC or IV doses in healthy participants and migraine patients.

Additional Study Details

Phase
Phase 1
Product
AMG 334
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
61
Additional Study Details

Protocol Summary

Primary Outcome Measures

The number of treatment emergent adverse events per subject, including changes in vital signs, physical and neurological examinations, laboratory safety tests and ECGs.

Timeframe: Up to 155 days

The number of subjects with anti-AMG 334 antibodies after a single dose of AMG 334.

Timeframe: Up to 155 days

Secondary Outcome Measures

The maximum observed concentration, time to maximum concentration and the area under the serum-concentration curve after a single dose of AMG 334.

Timeframe: Up to 155 days

The ratio of blood flow measure at 30 minute post capsaicin challenge to the blood flow measure prior to the capsaicin challenge.

Timeframe: Up to 155 days

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Leuven, Belgium, 3000
Status
Recruiting
Study Info
Age
18 - 55 Years
Condition
  • Migraine
    • Sex
    All
    Trial Dates
    Mar 2012 - Mar 2013
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Healthy male and female subjects between 18 and 45 years of age, or male or female subjects with migraines between 18 and 55 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician;
    Exclusion Criteria:
    - History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;