Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine Patients

NCT01688739 | Completed Phase 1 Results

• 2 other identifiers: 201012672011-005600-15
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of erenumab after single subcutaneous (SC) or intravenous (IV) doses in healthy participants and migraine patients as well as to characterize the effect of erenumab on the capsaicin-induced increase in dermal blood flow after single SC or IV doses in healthy participants and migraine patients.

Conditions

Migraine

Keywords

Migraine

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events. Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: * fatal * life-threatening (places the subject at immediate risk of death) * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.

  From the initial dose of study drug up to 155 days.

• Number of Participants Who Developed Anti-erenumab Antibodies

  Participants who had a negative or no result at baseline and were antibody positive postbaseline. Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.

  Baseline and up to 155 days postdose

Secondary Outcomes (5)

• Maximum Observed Concentration (Cmax) of Erenumab

  Predose to 155 days postdose

• Time to Maximum Observed Concentration (Tmax) of Erenumab

  Predose to 155 days postdose

• Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Erenumab

  Predose to 155 days postdose

• Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Erenumab

  Predose to 155 days postdose

• Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow

  Days 4, 15, 29, 43, 64, 85, 99, 127, and end of study (defined as day 43 for the 1 mg, 7 mg and 21 mg erenumab cohorts, day 99 for the 70 mg erenumab cohort, day 127 for the 140 mg erenumab cohorts and day 155 for the 210 mg erenumab cohort).

Study Arms (2)

Erenumab

EXPERIMENTAL

Participants received a single dose of erenumab by subcutaneous injection at doses of 1 mg, 7 mg, 21 mg, 70 mg, 140 mg, and 210 mg or by IV injection at a dose of 140 mg.

Drug: Erenumab

Placebo

PLACEBO COMPARATOR

Participants received a single dose of matching placebo administered by SC or IV injection.

Drug: Placebo

Interventions

Erenumab DRUG

Administered by subcutaneous injection or intravenous injection

Also known as: AMG 334, Aimovig™

Erenumab

Placebo DRUG

Administered by subcutaneous injection or intravenous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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;

You may not qualify if:

• \- 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;

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Research Site

Leuven, 3000, Belgium

Location

Related Publications (2)

• Vu T, Ma P, Chen JS, de Hoon J, Van Hecken A, Yan L, Wu LS, Hamilton L, Vargas G. Pharmacokinetic-Pharmacodynamic Relationship of Erenumab (AMG 334) and Capsaicin-Induced Dermal Blood Flow in Healthy and Migraine Subjects. Pharm Res. 2017 Sep;34(9):1784-1795. doi: 10.1007/s11095-017-2183-6. Epub 2017 Jun 7.

  PMID: 28593473 BACKGROUND

• de Hoon J, Van Hecken A, Vandermeulen C, Yan L, Smith B, Chen JS, Bautista E, Hamilton L, Waksman J, Vu T, Vargas G. Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine. Clin Pharmacol Ther. 2018 May;103(5):815-825. doi: 10.1002/cpt.799. Epub 2017 Oct 24.

  PMID: 28736918 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Migraine Disorders

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 20, 2012
• Study Start: March 13, 2012
• Primary Completion: March 27, 2013
• Study Completion: March 27, 2013
• Last Updated: January 18, 2019
• Results First Posted: January 18, 2019

Record last verified: 2018-08

Locations

BE (1)