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

Amgen

Status and phase: Completed; Phase 1

Conditions: Headache, Migraine

Treatments: Drug: Ethynil Estradiol/Norgestimate Oral Contraceptive; Drug: Erenumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02792517

20150334

Details and patient eligibility

About

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

Full description

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.

Enrollment: 41 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Erenumab + Estrogen/Progestin Contraceptive

Experimental group

Description:

Participants received a combination oral contraceptive for 3 28-day cycles during the study. A single 140 mg dose of erenumab was administered subcutaneously to the abdomen on day 10 of cycle 3 by a healthcare provider.

Treatment:

Drug: Erenumab

Drug: Ethynil Estradiol/Norgestimate Oral Contraceptive