Trial record 1 of 6 for:    AMG334
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Ascending Single Doses of AMG 334 in Healthy Subjects and Migraine Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01688739
First received: September 17, 2012
Last updated: January 8, 2014
Last verified: January 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 pharmacokinetics (PK) profile of AMG 334 after single SC or IV 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 single SC or IV doses in healthy subjects and migraine patients.


Condition Intervention Phase
Migraine
Drug: AMG 334
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: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 334 in Healthy Subjects and 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 155 days ] [ Designated as safety issue: Yes ]
    physical and neurological examinations, vitals, clinical laboratories, ECGs

  • The number of subjects with anti-AMG 334 antibodies after a single dose of AMG 334. [ Time Frame: Up to 155 days ] [ Designated as safety issue: Yes ]
    Lab analytes


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. [ Time Frame: Up to 155 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 blood flow measure prior to the capsaicin challenge. [ Time Frame: Up to 155 days ] [ Designated as safety issue: No ]
    Blood flow measure at 30 minute post capsaicin challenge to the blood flow measure prior to the capsaicin challenge.


Enrollment: 60
Study Start Date: March 2012
Study Completion Date: August 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMG 334 Treatment A
6 dose levels administered as single doses SC or IV in healthy subjects and migraine patients.
Drug: AMG 334
6 dose levels of AMG 334/Placebo administered as single doses SC or IV in healthy volunteers and migraine patients.
Placebo Comparator: AMG 334 Treatment B
6 dose levels administered as single doses SC or IV in healthy subjects and migraine patients.
Drug: AMG 334
6 dose levels of AMG 334/Placebo administered as single doses SC or IV in healthy volunteers and migraine patients.

Detailed Description:

In this single-dose, double-blind, placebo-controlled, sequential dose escalation study, a total of approximately 68 subjects will be randomized into 8 cohorts. Approximately 48 healthy subjects will be randomized into 6 cohorts: (5 SC cohorts and 1 IV cohort). A total of 12 migraine patients will be enrolled into cohort 7 and an additional 8 migraine patients may be enrolled into the optional Cohort 8.

  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 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;

  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: NCT01688739

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: NCT01688739     History of Changes
Other Study ID Numbers: 20101267, 2011-005600-15
Study First Received: September 17, 2012
Last Updated: January 8, 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
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014