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Study Complete
Sponsor ID
20150334

Erenumab (AMG 334) plus Combined Oral Contraceptive Drug Interaction Study in Healthy FemalesN/A

Sponsor ID
20150334
Clinicaltrials.gov ID
NCT02792517
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen.

Additional Study Details

Phase
Phase 1
Product
AMG 334
Type
Interventional
Masking
None (Open Label)
Enrollment
41
Additional Study Details

Protocol Summary

Primary Outcome Measures

The effect of AMG 334 on the minimum observed concentration of Estrogen/Progestin

Timeframe: 24 hours

The effect of AMG 334 on the maximum observed concentration of Estrogen/Progestin

Timeframe: 24 hours

The effect of AMG 334 on the time to maximum plasma concentration of Estrogen/Progestin

Timeframe: 24 hours

The effect of AMG 334 on the area under the plasma concentration curve of Estrogen/Progestin

Timeframe: 24 hours

Secondary Outcome Measures

Additional measures of Estrogen/Progestin for maximum observed concentration

Timeframe: 24 hours

Additional measures of Estrogen/Progestin for time to maximum concentration

Timeframe: 24 hours

Additional measures of Estrogen/Progestin for the area under the plasma concentration curve

Timeframe: 24 hours

The number of treatment emergent adverse events

Timeframe: 24 hours

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Cypress, CA, United States, 90630
Status
Completed
Location
Research Site
Madison, WI, United States, 53704
Status
Completed
Location
Research Site
Anaheim, CA, United States, 92801
Status
Completed
Location
Research Site
Dallas, TX, United States, 75247
Status
Completed
Study Info
Age
18 - 45 Years
Condition
  • Migraine
    • Sex
    Assigned Female at Birth
    Trial Dates
    Feb 2016 - Sep 2016
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    -Healthy female ≥18 to ≤45 years old at the time of enrollment -Regular monthly menstrual cycle during the last 12 months -Good general health based on a medical history evaluation and physical examination -No clinically significant abnormalities in laboratory tests at screening -Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures
    Exclusion Criteria:
    -Intolerance to any recent oral contraceptive in the last three (3) years, -Female subjects with a positive serum pregnancy test at screening -Female subjects not willing to inform her sexual partner of her participation in the clinical study -Use of any over the counter or prescription medications within the 14 days or 5 half lives (whichever is longer) -Nicotine use eg cigarettes or equivalent during 12 months prior to day 1 and through the duration of the study