Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females
NCT ID: NCT02792517
Last Updated: 2018-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2016-02-12
2016-09-09
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Erenumab + Estrogen/Progestin Contraceptive
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.
Erenumab
A single dose of erenumab administered in the abdomen.
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.
Interventions
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Erenumab
A single dose of erenumab administered in the abdomen.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Anaheim, California, United States
Research Site
Cypress, California, United States
Research Site
Dallas, Texas, United States
Research Site
Madison, Wisconsin, United States
Countries
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References
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Xu Y, Gabriel K, Wang Y, Zhou Y, Eisele O, Vutikullird A, Mikol DD, Lee E. A Multi-Center, Open-Label, Pharmacokinetic Drug Interaction Study of Erenumab and a Combined Oral Contraceptive in Healthy Females. CNS Drugs. 2019 May;33(5):513-522. doi: 10.1007/s40263-019-00626-2.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20150334
Identifier Type: -
Identifier Source: org_study_id