Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females

• Status: Completed
• Trial end date: 2016-09-09
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amgen
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Erenumab; Estradiol; Estrogens; Norgestimate; Progestins

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