Phase I, Double-Blind,Placebo, MAD Study to Evaluate the Safety, Tolerability, PK, and PD of AMG 333 in Healthy Subjects and Migraine Subjects

NCT02132429 | Terminated Phase 1

• 1 other identifier: 20130246
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of AMG 333 for 14 days in healthy subjects and migraine subjects. As part of the secondary objectives, the study will characterize the pharmacokinetic (PK) profile of AMG 333 after multiple oral doses in healthy subjects and migraine subjects, as well as characterize the effect of multiple doses of AMG 333 on increases in blood pressure (BP) induced by the cold pressor test (CPT) in healthy subjects.

Conditions

Migraine

Keywords

Migraine

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent AEs

  Treatment-emergent adverse events, including changes in vital signs, 12-lead ECGs, clinical laboratory safety tests, and physical and neurological assessments

  Up to 29 Days

Secondary Outcomes (4)

• Plasma PK Parameter

  Up to 29 Days

• Plasma PK Parameter

  Up to 29 Days

• Plasma PK Parameter

  Up to 29 Days

• Blood Pressure response to CPT

  Up to 29 Days

Study Arms (2)

AMG 333

EXPERIMENTAL

Subjects will receive a single oral dose of AMG 333 daily for 14 days.

Drug: AMG 333

Placebo

PLACEBO COMPARATOR

Subjects will receive a single oral dose of placebo daily for 14 days.

Drug: Placebo

Interventions

AMG 333 DRUG

Oral administration available in varying dose strength.

AMG 333

Placebo DRUG

Placebo containing no active drug

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 (cohorts 1 through 5) and male and female subjects with migraines (cohort 6), who are ≥ 18 and ≤ 55 years of age at the time of screening, and have 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 a clinically significant disorder, condition, or disease that in the opinion of the investigator and Amgen physician, would significantly impair pain perception (eg, history of stroke, history of neuropathy), would pose a risk to subject safety or interfere with evaluation, procedures, or study completion.

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

CRI Lifetree

Salt Lake City, Utah, 84106, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Migraine Disorders

Interventions

AMG 333

Condition Hierarchy (Ancestors)

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

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 7, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

US (1)