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

Migraine Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 333 in Healthy Subjects and Subjects With Migraines.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953341
• Other study ID #: 20130102
• Status: Completed
• Phase: Phase 1
• First received: September 26, 2013
• Last updated: December 8, 2014
• Start date: October 2013
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• AMG 333
Oral administration available in varying dose strength.
• Placebo
Placebo containing no active drug

Locations

Country	Name	City	State
United States	Research Site	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary	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	Yes
Primary	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	Up to 29 days	Yes
Secondary	Secondary Outcome Measures	Time to maximum concentration [Tmax])	Up to 29 Days	Yes
Secondary	Secondary	Change in systolic and diastolic blood pressure in response to Cold Pressor Test (CPT)	Up to 29 days	No
Secondary	Secondary Outcome Measures	Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration [AUClast]	Up to 29 Days	Yes
Secondary	Secondary Outcome Measures	Area under the concentration-time curve from time 0 extrapolated to infinity [AUCinf], maximum observed concentration [Cmax], and T1/2)	Up to 29 Days	Yes

External Links

•   AmgenTrials clinical trials website