NCT02792517

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

A Multi-Center, Open-label, Pharmacokinetic Drug Interaction Study of AMG 334 and a Combined Oral Contraceptive in Healthy Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Headache, Migraine

Interventions

Type	Name	Description
DRUG	Erenumab	A single dose of erenumab administered in the abdomen.
DRUG	Ethynil Estradiol/Norgestimate Oral Contraceptive	Ethynil estradiol (EE)/norgestimate combination oral contraceptive is a 28-tablet cycle in which 1 oral tablet is taken daily; each containing 0.250 mg norgestimate and 0.035 mg EE for 21 days, after which a tablet only containing inert ingredients is taken for last 7 days of the 28 day cycle.

Timeline

• Start date: 2016-02-12
• Primary completion: 2016-09-09
• Completion: 2016-09-09
• First posted: 2016-06-07
• Last updated: 2018-12-20
• Results posted: 2018-12-20

Locations

4 sites across 1 country: United States