NCT04818515

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

A Phase 1b, Open-label, Fixed-sequence, Safety, Tolerability and Drug-drug Interaction Study Between Atogepant and Ubrogepant in Participants With a History of Migraine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. This study will assess the drug to drug interaction between atogepant and ubrogepant and assess the safety of atogepant and ubrogepant, when given alone or in combination, in adult participants with migraine. Atogepant is an investigational (unapproved) drug for the preventative treatment of migraine. Ubrogepant is a drug approved for the acute treatment of migraine. Adult participants with a history of migraine will be enrolled. Approximately, 30 participants will be enrolled in the study in multiple sites in the United States. Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination. The study duration will be 30 days with a 7 day follow period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, telephone assessments, blood tests, checking for side effects, and clinician-rated assessments.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Atogepant	Oral; Tablet
DRUG	Ubrogepant	Oral; Tablet

Timeline

• Start date: 2021-03-17
• Primary completion: 2021-06-18
• Completion: 2021-06-18
• First posted: 2021-03-26
• Last updated: 2022-06-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study