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Ascending Multiple-Doses of AMG 334 in Healthy Subjects and in Migraine Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01723514
First received: November 6, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

The primary purpose of this study is to determine whether AMG 334 is safe and well tolerated in healthy subjects and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of AMG 334 after multiple SC doses in healthy subjects and migraine patients, as well as to characterize the effect of AMG 334 on the capsaicin induced increase in dermal blood flow after multiple SC doses in healthy subjects and migraine patients.


Condition Intervention Phase
Migraine
Drug: AMG 334
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 334 in Healthy Subjects and in Migraine Patients

Resource links provided by NLM:


Further study details as provided by Amgen:

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. [ Time Frame: Up to 197 days ] [ Designated as safety issue: Yes ]
    physical and neurological examinations, vitals, clinical laboratories, ECGs


Secondary Outcome Measures:
  • The maximum observed concentration, time to maximum concentration and the area under the serum-concentration curve after multiple doses of AMG 334. [ Time Frame: Up to 197 days ] [ Designated as safety issue: No ]
    Concentration time profiles for AMG 334

  • The ratio of blood flow measure at 30 minute post capsaicin challenge to the flow measure prior to the capsaicin challenge. [ Time Frame: Up to 197 days ] [ Designated as safety issue: No ]
    Blood flow measure at 30 minute post dose capsaicin challenge to the blood flow measure prior to the capsaicin challenge


Enrollment: 48
Study Start Date: November 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMG 334 Treatment A
3 dose levels administered as multiple SC doses in healthy subjects and migraine patients
Drug: AMG 334
3 dose levels of AMG 334 administered as multiple SC doses in healthy subjects and migraine patients.
Placebo Comparator: AMG 334 Treatment B
3 dose levels administered as multiple SC doses in healthy subjects and migraine patients
Drug: Placebo
3 dose levels of Placebo administered as multiple SC doses in healthy subjects and migraine patients.

Detailed Description:

In this ascending multiple dose, double blind, placebo controlled study, a total of 40 subjects will be randomized into 5 cohorts. Approximately 24 HS will be randomized into 3 cohorts (A1, A2, and A3), and 16 migraine patients will be randomized into 2 cohorts (B1 and B2). Each subject will receive a total of 3 SC doses of AMG 334 or placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Healthy male and female subjects, as well as 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;

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723514

Locations
Belgium
Research Site
Leuven, Belgium, 3000
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01723514     History of Changes
Other Study ID Numbers: 20101268
Study First Received: November 6, 2012
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products (FAMHP-AFMPS)
Belgium: Medical Ethics of the University Hospitals K.U. Leuven

Keywords provided by Amgen:
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014