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Abstract Details

Single Therapeutic Doses of Atogepant Are Not Associated With a Clinically Relevant Drug-Drug Interaction When Coadministered With Acetaminophen or Naproxen
Headache
Headache Posters (7:00 AM-5:00 PM)
098
To assess the drug-drug interaction potential of atogepant and acetaminophen or naproxen.
Atogepant is an oral calcitonin gene?related peptide receptor antagonist in development for preventive treatment of migraine.
Pharmacokinetic (PK) interactions between atogepant 60 mg and acetaminophen 1000 mg or naproxen 500 mg were assessed in a phase 1, open-label, randomized, single-center, 5-way crossover study. Healthy adults aged 18-45 years were randomized to 1 of 10 sequences of 5 treatment periods—atogepant alone, acetaminophen or naproxen alone, and atogepant plus acetaminophen or naproxen (all single doses)—with 7-day washout between periods.
Of 40 participants enrolled, 35 (87.5%) completed the study. Three participants withdrew consent and 2 were lost to follow-up. Participants in the statistical analyses of the PK parameters were as follows: n=38, atogepant alone; n=39, acetaminophen alone; n=37, coadministration of atogepant and acetaminophen; n=36, naproxen alone; and n=38, coadministration of atogepant and naproxen. Time to reach maximum plasma concentration, overall systemic exposure, and terminal elimination half-life for all study medications were generally unchanged when coadministered. There was no statistically significant or clinically relevant change in the PK of atogepant when coadministered with acetaminophen or naproxen. Similarly, there was no statistically significant or clinically relevant change in PK of naproxen and acetaminophen when coadministered with atogepant. The overall incidences of treatment-emergent adverse events (TEAEs) were low and most TEAEs were mild in intensity. The proportions of participants with TEAEs considered related to study intervention ranged from 2.8% to 13.2% across the 5 study interventions. The only TEAE considered related to study intervention reported for more than one participant in a given study intervention group was nausea following coadministration of atogepant with acetaminophen (n=2).
Coadministration of atogepant with either acetaminophen or naproxen was safe and well tolerated.
Authors/Disclosures

PRESENTER 		No disclosure on file
Abhijeet Jakate, PhD (Allergan Plc) No disclosure on file
No disclosure on file
No disclosure on file