Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines

Phase 1CompletedNCT01953341

Amgen74 enrolled

Overview

The primary purpose of this study is to determine whether AMG 333 is safe and well tolerated in healthy subjects and subjects with migraines. As part of the secondary objectives, this study will characterize the pharmacokinetic (PK) profile of AMG 333, as well as characterize the effect of AMG 333 on the cold pressor test (CPT)-induced increase in blood pressure after single oral doses in healthy subjects and subjects with migraines

This is a randomized, double-blind, placebo-controlled, ascending single-dose study evaluating AMG 333 in healthy subjects and subjects with migraines. The study will consist of 8 cohorts: 7 cohorts of healthy subjects and 1 cohort of subjects with migraines. For cohorts 1 to 7, 8 subjects each will be enrolled, and subjects will be randomized such that 6 subjects will receive AMG 333 and 2 subjects will receive placebo (3:1 ratio). In cohort 8, up to 24 subjects with migraines will be enrolled, depending on enrollment rate and emerging safety and tolerability data. These migraine subjects will be randomized to receive AMG 333 or placebo in a crossover fashion. Both healthy and migraine subjects will be monitored in house for 4 days then allowed to return home for the remainder of the 14 day observation period. Both healthy and migraine subjects will keep headache diaries.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Migraine

Interventions

AMG 333DRUG

Oral administration available in varying dose strength.

PlaceboDRUG

Placebo containing no active drug

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and female subjects with or without migraines ≥18 and ≤55 years of age at the time of screening, 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 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) or interfere with evaluation, procedures, or study completion.

Locations (1)

Research Site

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Primary

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

Time frame: Up to 29 days

Primary

Headache assessment as measured by the occurrence of moderate-to-severe headache within 36 hours of treatment, as well as number of moderate-to-severe headaches within 4 days of dosing

Time frame: Up to 29 days

Secondary Outcomes

Secondary Outcome Measures

Time to maximum concentration \[Tmax\])

Time frame: Up to 29 Days

Secondary

Change in systolic and diastolic blood pressure in response to Cold Pressor Test (CPT)

Time frame: Up to 29 days

Secondary Outcome Measures

Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration \[AUClast\]

Time frame: Up to 29 Days

Secondary Outcome Measures

Area under the concentration-time curve from time 0 extrapolated to infinity \[AUCinf\], maximum observed concentration \[Cmax\], and T1/2)

Time frame: Up to 29 Days

Data from ClinicalTrials.gov

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