ArticleHeadache
Milk and plasma pharmacokinetics of single-dose ubrogepant in healthy lactating women.
Article in Headache. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05892757 (A Phase 1 Lactation Study in Healthy Adult Lactating Female Subjects One to Six Months Post-Partum to Evaluate the Pharmacokinetics and Safety of Ubrogepant and Atogepant), which is not on this map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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A Phase 1 Lactation Study in Healthy Adult Lactating Female Subjects One to Six Months Post-Partum to Evaluate the Pharmacokinetics and Safety of Ubrogepant and Atogepant
Who cites it
2 citing papers in PubMed.
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Authors and funding
4 authors.
Funding
Abstract
objectiveThe objectives of this study were to evaluate the safety, plasma and milk pharmacokinetics, excretion in breast milk, and the relative infant dose of ubrogepant following a single oral dose.
backgroundUbrogepant is a calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine in adults. Preclinical findings in rats demonstrated comparable concentrations of ubrogepant in milk versus plasma; however, the quantification of ubrogepant excretion in human breast milk and breastfed infant exposure have not been previously evaluated.
methodsThis open-label, phase 1 study (NCT05892757) enrolled healthy, lactating adult women from July 11, 2023, to February 22, 2024. Participants were 1-6 months postpartum and received a single dose of ubrogepant 100 mg (2 × 50 mg tablets) orally. Plasma and breast milk samples were collected for up to 24 h after dosing to evaluate pharmacokinetics and ubrogepant concentrations were determined using validated liquid chromatography tandem mass spectrometry assays. Standard pharmacokinetic parameters were calculated from the plasma concentration and breast milk data using non-compartmental analyses. The milk-to-plasma concentration ratio was calculated based on the ratio of the area under the plasma concentration-time curve from time 0 to infinity (AUC
resultsA total of 12 women were enrolled who each received a single dose of oral ubrogepant 100 mg. The mean milk-to-plasma ratio was 0.23, the cumulative amount of ubrogepant excreted in breast milk was <0.02% and the calculated relative infant dose was 0.15%. The maximum observed breast milk concentration and AUC of ubrogepant in breast milk were significantly lower (75% and 78%, respectively) compared to plasma. Only two mild adverse events were reported.
conclusionLess than 0.02 mg of a 100 mg dose of ubrogepant was excreted in breast milk over a 24-h period. The minimal transfer of ubrogepant into breast milk is not considered clinically relevant.
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