Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers

Study Identifier
M22-394
CT.gov Identifier
NCT05892757
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Healthy Volunteer
    • Study Drug
  • Atogepant
  • Ubrogepant
    • Phase
    Phase 1
    Sex
    Female
    Age
    18 - 45 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Healthy, lactating, female volunteers who delivered one or more normal-term infants and established lactation from 1 - 6 months post-partum at the time of enrollment. * Had a normal pregnancy (gestation of 37-42 weeks) with no clinically significant complications. * Willing to permit the use of pasteurized donor milk, infant formula, or previously pumped/stored human milk to feed the infant. * Agree to the use of provided breast pumps for the pumping of breast milk during the milk collection regimen of the study.
    Exclusion Criteria:
    \- Prior exposure to ubrogepant or atogepant within the past 30 days.

    Protocol Summary

    This study will assess adverse events and compare how ubrogepant and atogepant tablets move through the body of healthy adult lactating female participants.

    Ubrogepant and atogepant are approved drugs for treatment of migraine in adults. Participants will be assigned to one of the 2 treatment arms to receive atogepant or ubrogepant. Approximately 24 healthy adult lactating female participants will be enrolled at 3 sites in the United States

    Participants will receive oral tablets of ubrogepant or atogepant on Day 1 and will be followed for 30 days.

    Study Locations

    Location
    Status
    Location
    Bio-Kinetic Clinical Applications, LLC /ID# 255452
    Springfield, Missouri, United States, 65802
    Status
    Not applicable
    Location
    Icon /Id# 257524
    San Antonio, Texas, United States, 78209
    Status
    Not applicable
    Location
    Icon /Id# 257525
    Salt Lake City, Utah, United States, 84124
    Status
    Not applicable