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

A pharmacokinetic (PK) drug interaction study of erenumab and an oral contraceptive
containing progestin and estrogen. All participants will receive an oral contraceptive
containing progestin and estrogen throughout the duration of the study. Participants will
also receive a single dose of erenumab, administered by a healthcare provider in cycle 3.
Serial PK samples will be collected at specified time points to characterize the PK of the
oral contraceptive progestin and estrogen components with and without the presence of
erenumab.

The study consists of three 28-day cycles and a follow-up period. The first 28 day cycle is
an acclimation period when participants initiate oral contraception (Cycle 1). During Cycle 2
and 3 the PK of ethinyl estradiol (EE) and active metabolites of norgestimate (ie,
norelgestromin [NGMN] and norgestrel [NG]) will be characterized following the last active
dose of oral contraceptive in each cycle (cycle day 21). Erenumab will be given in cycle 3
(cycle day 10); 24-hour PK characterization of norgestimate and EE metabolites will occur 11
days after administration of erenumab, which will maximize the potential for detecting a
drug-drug interaction.

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