Ascending Multiple-Doses of AMG 334 in Healthy Subjects and in Migraine Patients
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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 |
- 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
- 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
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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 |
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 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: | May 6, 2013 |
| 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 May 19, 2013