Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine

This is an interventional treatment trial for Migraine focused on measuring Migraine, Atogepant, Ubrogepant, UBRELVY Read More

Inclusion Criteria:

• At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) (2018) and is eligible for preventive migraine treatment.
• By history, the participant's migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom.
• History of at least 2 migraine attacks per month in the 2 months prior to screening.
• Sitting heart rate ≥ 45 bpm and ≤ 100 bpm during the vital signs assessment at the Screening Visit. The clinical site may perform a maximum of 2 repeats of vital sign measurements if the initial measurement is out of range.
• Negative test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, cannabinoids, opiates, and phencyclidine at the Screening Visit and Day -1; unless explained by concomitant medication use (eg, opioids prescribed for migraine pain).
• Must be a nonsmoker and a nonuser of nicotine-containing products (never smoked or used nicotine-containing products or has not smoked or used nicotine-containing products within the previous 2 years, including eCigarettes).

Exclusion Criteria:

• Difficulty distinguishing migraine headache from tension-type or other headaches.
• Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
• Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3.
• Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to screening.
• Has a chronic non-headache pain condition requiring daily pain medication (with the exception of pregabalin).

• Clinically significant cardiovascular or cerebrovascular disease per the investigator's opinion including, but not limited to:

  • Clinically significant ischemic heart disease (eg, unstable angina pectoris).
  • Clinically significant cardiac rhythm or conduction abnormalities (eg, atrial fibrillation, second- or third-degree heart block) or risk factors for torsade de pointes (eg, heart failure, hypokalemia, bradycardia).
  • Myocardial infarction, transient ischemic attack, or stroke within 6 months prior to screening.
  • Heart failure defined as New York Heart Association functional classification system Class III or IV.
• Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
• In the opinion of the investigator, other confounding pain syndromes, confounding psychiatric conditions, dementia, epilepsy, or other significant neurological disorders other than migraine.
• History of malignancy in the 5 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
• History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) or previous surgery that may affect the absorption or metabolism of study interventions; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded.
• History of acute hepatitis within 6 months of screening or chronic hepatitis (including nonalcoholic steatohepatitis) or a positive result on anti-human immunodeficiency virus (HIV) type 1 and type 2 antibody, hepatitis B surface antigen (HBsAg), or anti-hepatitis C antibody testing at screening.
• Coronavirus disease 2019 (COVID-19) infection and/or COVID-19 or flu-like symptoms within 14 days of Day 1, including fever, cough, difficulty breathing.
• Close contact with anyone who has a COVID-19 infection within 14 days before Day 1.