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Abstract Details

Coadministration of Single Therapeutic Oral Doses of Atogepant and Sumatriptan Produces No Clinically Relevant Drug-Drug Interactions
Headache
Headache Posters (7:00 AM-5:00 PM)
101
Atogepant is an oral calcitonin gene?related peptide receptor antagonist in development for preventive treatment of migraine. 
Single-center, open-label, randomized, phase 1, pharmacokinetic (PK) study examined the potential for PK drug-drug interaction between atogepant and sumatriptan.
Healthy adults (N=30) aged 18–45 years were randomized to 1 of 6 sequences to receive 3 single-dose oral treatments: atogepant 60 mg, sumatriptan 100 mg, and atogepant 60 mg plus sumatriptan 100 mg. This 3-way crossover design included study drug administration on days 1, 8, and 15, a 7-day washout period between treatments, and a safety visit 30 days after the last treatment. Pre- and post-dose blood samples were used to evaluate the potential for PK drug-drug interaction as the primary endpoint. 
Of 30 participants enrolled, 27 (90%) completed the study. Three participants discontinued due to positive urine drug screens. For atogepant, the median time to achieve maximum plasma concentration (Tmax) was delayed by 1.5 hours when coadministered with sumatriptan vs administration alone, while the mean apparent terminal half-life (t½) was generally similar. Comparison of the geometric least squares means showed that atogepant maximum plasma concentration (Cmax) was 22% lower after coadministration with sumatriptan vs administration alone. Atogepant area under the plasma concentration-time curve for time 0 to t (AUC0-t) and to infinity (AUC0-∞) were lower by 5% when coadministered with sumatriptan. For sumatriptan, the median Tmax and t½ were similar when administered alone or coadministered with atogepant. There was no significant change in sumatriptan Cmax (5% reduction), AUC0-t (2% increase), or AUC0-∞ (2% increase) after coadministration with atogepant vs administration alone. Incidence of any treatment-emergent adverse event was low (4 of 30 participants: atogepant alone n=0; sumatriptan alone n=2; coadministration n=2), and all were mild in severity. 
Coadministration of atogepant with sumatriptan was safe and well tolerated, with no safety concerns identified.
Authors/Disclosures
Matthew Butler
PRESENTER
Matthew Butler has received personal compensation for serving as an employee of Allergan / Abbvie. Matthew Butler has received stock or an ownership interest from Allergan/Abbvie.
Abhijeet Jakate, PhD (Allergan Plc) No disclosure on file
Antonia Periclou Antonia Periclou has received personal compensation for serving as an employee of Allergan/AbbVie. Antonia Periclou has received stock or an ownership interest from Allergan/AbbVie.
Ramesh *use 388303 Boinpally Ramesh Boinpally has received personal compensation for serving as an employee of Allergan/Abbvie. Ramesh Boinpally has stock in Abbvie. Ramesh Boinpally has stock in Allergan. Ramesh Boinpally has received intellectual property interests from a discovery or technology relating to health care.