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

Migraine Clinical Trial

Official title:

Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 333 in Healthy Subjects and Migraine Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02132429
• Other study ID #: 20130246
• Status: Terminated
• Phase: Phase 1
• First received: May 5, 2014
• Last updated: March 30, 2015
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• 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 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.

Description:

This is a randomized, double-blind, placebo-controlled, ascending multiple-dose study evaluating AMG 333 in healthy subjects and subjects with migraines. Eight healthy subjects will be enrolled in each of cohorts 1 through 5. Study subjects will be randomized such that 6 subjects will receive AMG 333 and 2 subjects will receive placebo (3:1 ratio) per cohort. Likewise, 8 migraine subjects will be enrolled in cohort 6 and randomized to receive AMG 333 or placebo (3:1 ratio). All subjects will be housed for 15 days then allowed to return home. Migraine subjects will self-administer the headache diary at least once daily during the screening and out-patient portions of the study, and site personnel will administer the headache diary during the in-house period of the study. Healthy subjects will not keep the headache diary during screening and will have the headache diary administered by site personnel at least once daily starting on day 1 through day 14, and will then self administer throughout their participation in the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

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), would pose a risk to subject safety 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	CRI Lifetree	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	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	Yes
Secondary	Plasma PK Parameter	Plasma PK parameters of AMG 333: time to maximum concentration (tmax)	Up to 29 Days	Yes
Secondary	Plasma PK Parameter	Maximum observed concentration (Cmax)	Up to 29 Days	Yes
Secondary	Plasma PK Parameter	Area Under the Concentration Time-Curve from time 0 to 24 hours postdose (AUC0-24) and Days 1 and 14	Up to 29 Days	Yes
Secondary	Blood Pressure response to CPT	Change in systolic and diastolic BP in response to the CPT in healthy subjects.	Up to 29 Days	No

External Links

•   AmgenTrials clinical trials website