A Multi-Center, Open-Label, Pharmacokinetic Drug Interaction Study of Erenumab and a Combined Oral Contraceptive in Healthy Females.
Adolescent
Adult
Antibodies, Monoclonal, Humanized
/ administration & dosage
Area Under Curve
Calcitonin Gene-Related Peptide Receptor Antagonists
/ administration & dosage
Contraceptives, Oral, Combined
/ administration & dosage
Drug Combinations
Drug Interactions
Ethinyl Estradiol
/ administration & dosage
Female
Follicle Stimulating Hormone
/ blood
Healthy Volunteers
Humans
Luteinizing Hormone
/ blood
Metabolic Clearance Rate
Middle Aged
Norgestrel
/ administration & dosage
Progesterone
/ blood
Young Adult
Journal
CNS drugs
ISSN: 1179-1934
Titre abrégé: CNS Drugs
Pays: New Zealand
ID NLM: 9431220
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
pubmed:
10
4
2019
medline:
29
8
2020
entrez:
10
4
2019
Statut:
ppublish
Résumé
Erenumab is a human anti-calcitonin gene-related peptide monoclonal antibody developed for migraine prevention. Migraine predominately affects women of childbearing age; thus, it is important to determine potential drug-drug interactions between a common oral contraceptive and drugs used to treat migraine. We sought to evaluate potential drug-drug interactions between erenumab and a common oral contraceptive. Healthy women received three cycles of a norgestimate/ethinyl estradiol-containing oral contraceptive with a single 140-mg subcutaneous dose of erenumab during cycle three. Norgestimate metabolites (norgestrel and norelgestromin) and ethinyl estradiol pharmacokinetics were evaluated in the absence and presence of erenumab. Primary endpoint was peak plasma concentration (C Erenumab did not influence the pharmacokinetics of norelgestromin, norgestrel, or ethinyl estradiol. Least-squares mean estimates (90% confidence interval) for C Erenumab did not alter the pharmacokinetics of the active components of an estrogen/progestin combination oral contraceptive. Thus, no change in contraceptive efficacy is expected with erenumab. ClinicalTrials.gov NCT02792517.
Sections du résumé
BACKGROUND
Erenumab is a human anti-calcitonin gene-related peptide monoclonal antibody developed for migraine prevention. Migraine predominately affects women of childbearing age; thus, it is important to determine potential drug-drug interactions between a common oral contraceptive and drugs used to treat migraine.
OBJECTIVES
We sought to evaluate potential drug-drug interactions between erenumab and a common oral contraceptive.
METHODS
Healthy women received three cycles of a norgestimate/ethinyl estradiol-containing oral contraceptive with a single 140-mg subcutaneous dose of erenumab during cycle three. Norgestimate metabolites (norgestrel and norelgestromin) and ethinyl estradiol pharmacokinetics were evaluated in the absence and presence of erenumab. Primary endpoint was peak plasma concentration (C
RESULTS
Erenumab did not influence the pharmacokinetics of norelgestromin, norgestrel, or ethinyl estradiol. Least-squares mean estimates (90% confidence interval) for C
CONCLUSION
Erenumab did not alter the pharmacokinetics of the active components of an estrogen/progestin combination oral contraceptive. Thus, no change in contraceptive efficacy is expected with erenumab.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02792517.
Identifiants
pubmed: 30963506
doi: 10.1007/s40263-019-00626-2
pii: 10.1007/s40263-019-00626-2
pmc: PMC6520319
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Calcitonin Gene-Related Peptide Receptor Antagonists
0
Contraceptives, Oral, Combined
0
Drug Combinations
0
norgestimate, ethinyl estradiol drug combination
0
Norgestrel
3J8Q1747Z2
Ethinyl Estradiol
423D2T571U
Progesterone
4G7DS2Q64Y
Luteinizing Hormone
9002-67-9
Follicle Stimulating Hormone
9002-68-0
erenumab
I5I8VB78VT
Banques de données
ClinicalTrials.gov
['NCT02792517']
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
513-522Commentaires et corrections
Type : ErratumIn
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