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Single Therapeutic and Supratherapeutic Doses of Ubrogepant Do Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized Trial
- Source :
- Clinical Pharmacology and Therapeutics
- Publication Year :
- 2019
- Publisher :
- Wiley, 2019.
-
Abstract
- Ubrogepant is a novel, oral calcitonin gene-related peptide receptor antagonist currently under US Food and Drug Administration (FDA) review for the acute treatment of migraine attacks. This double-blind, four-period crossover study compared the cardiac repolarization effect of therapeutic (100 mg) and supratherapeutic (400 mg) ubrogepant doses vs. placebo in healthy adults. Moxifloxacin 400 mg was used as an open-label active control, and the primary end point was change from baseline in Fridericia-corrected QT intervals (ΔQTcF). Assay sensitivity was demonstrated via statistically significant QTcF prolongation with moxifloxacin vs. placebo. After single oral doses of ubrogepant, the least squares mean placebo-corrected ΔQTcF (ΔΔQTcF) and 90% confidence intervals (CIs) did not exceed the 10-millisecond regulatory threshold at any timepoint. The 90% CI upper bounds were 2.46 milliseconds and 2.69 milliseconds for ubrogepant 100 and 400 mg, respectively. Categorical and concentration-based analyses were consistent with the primary result, showing no significant impact of ubrogepant on cardiac repolarization.
- Subjects :
- Adult
Male
medicine.medical_specialty
Adolescent
Pyridines
Placebo
030226 pharmacology & pharmacy
QT interval
Article
Young Adult
03 medical and health sciences
0302 clinical medicine
Calcitonin gene-related peptide receptor antagonist
Double-Blind Method
Calcitonin Gene-Related Peptide Receptor Antagonists
Heart Rate
Moxifloxacin
Internal medicine
medicine
Humans
Pyrroles
Pharmacology (medical)
Pharmacology
Cross-Over Studies
Dose-Response Relationship, Drug
business.industry
Research
QTcF Prolongation
Articles
Assay sensitivity
Middle Aged
Crossover study
Healthy Volunteers
Confidence interval
030220 oncology & carcinogenesis
Cardiology
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 15326535 and 00099236
- Volume :
- 107
- Database :
- OpenAIRE
- Journal :
- Clinical Pharmacology & Therapeutics
- Accession number :
- edsair.doi.dedup.....609d52851993427ca9815f60a0b51bc3