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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

November 6, 2012
July 24, 2014
November 2012
July 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01723514 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Ascending Multiple-Doses of AMG 334 in Healthy Subjects and in Migraine Patients
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Migraine
  • Drug: AMG 334
    3 dose levels of AMG 334 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.
  • Active Comparator: AMG 334 Treatment A
    3 dose levels administered as multiple SC doses in healthy subjects and migraine patients
    Intervention: Drug: AMG 334
  • Placebo Comparator: AMG 334 Treatment B
    3 dose levels administered as multiple SC doses in healthy subjects and migraine patients
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
July 2014
July 2014   (final data collection date for primary outcome measure)

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;

Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01723514
20101268
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP