Headache, Migraine Clinical Trial
Official title:
A Multi-Center, Open-label, Pharmacokinetic Drug Interaction Study of AMG 334 and a Combined Oral Contraceptive in Healthy Female Subjects
A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen.
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.
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