A Multi-Center, Open-Label, Pharmacokinetic Drug Interaction Study of Erenumab and a Combined Oral Contraceptive in Healthy Females
| Autor: | Apinya Vutikullird, Daniel D. Mikol, Edward Lee, Yang Xu, Yanchen Zhou, Osaro Eisele, Kristin Gabriel, Yi Wang |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Adolescent Metabolic Clearance Rate medicine.drug_class Cmax Physiology Antibodies Monoclonal Humanized Ethinyl Estradiol Young Adult 03 medical and health sciences 0302 clinical medicine Pharmacokinetics Calcitonin Gene-Related Peptide Receptor Antagonists Norgestrel medicine Humans Norelgestromin Drug Interactions Pharmacology (medical) Original Research Article Progesterone business.industry Correction Luteinizing Hormone Middle Aged Norgestimate Healthy Volunteers 030227 psychiatry Contraceptives Oral Combined Drug Combinations Psychiatry and Mental health Estrogen Area Under Curve Female Neurology (clinical) Follicle Stimulating Hormone business Luteinizing hormone Progestin 030217 neurology & neurosurgery hormones hormone substitutes and hormone antagonists medicine.drug |
| Zdroj: | CNS Drugs |
| ISSN: | 1179-1934 1172-7047 |
| Popis: | 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 (Cmax) and area under concentration-time curve from time 0 to 24 h (AUCtau). Luteinizing hormone, follicle-stimulating hormone, and progesterone concentrations were evaluated as pharmacodynamic markers. Results Erenumab did not influence the pharmacokinetics of norelgestromin, norgestrel, or ethinyl estradiol. Least-squares mean estimates (90% confidence interval) for Cmax ratios were 1.05 (0.90–1.23), 1.06 (0.97–1.16), and 1.04 (0.88–1.22) for norelgestromin, norgestrel, and ethinyl estradiol, respectively. Respective AUCtau ratios were 1.02 (0.94–1.12), 1.03 (0.96–1.10), and 1.02 (0.91–1.14). Luteinizing hormone, follicle-stimulating hormone, and progesterone concentrations were similar after exposure to oral contraceptive alone and with erenumab. 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink