Overview

This trial is active, not recruiting.

Condition migraine
Treatments amg 334, placebo
Phase phase 1
Sponsor Amgen
Start date November 2012
End date July 2014
Trial size 48 participants
Trial identifier NCT01723514, 20101268

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
3 dose levels administered as multiple SC doses in healthy subjects and migraine patients
amg 334
3 dose levels of AMG 334 administered as multiple SC doses in healthy subjects and migraine patients.
(Placebo Comparator)
3 dose levels administered as multiple SC doses in healthy subjects and migraine patients
placebo
3 dose levels of Placebo administered as multiple SC doses in healthy subjects and migraine patients.

Primary Outcomes

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

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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;

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Amgen.