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

Part of paid clinical trials in Springfield, Missouri.

Sponsor
AbbVie
Study ID
NCT05892757
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 11, 2023
Status verified
Mar 2024
Primary completion
Feb 22, 2024
Completion
Feb 22, 2024

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Atogepant
    Participants will receive single dose of atogepant on Day 1.
  • Active Comparator: Ubrogepant
    Participants will receive single dose of ubrogepant on Day 1.

Primary Outcome Measure

Number of Participants Experiencing Adverse Events [ Time Frame: Up to Day 30 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Bio-Kinetic Clinical Applications, LLC /ID# 255452SpringfieldMissouri65802-
Icon /Id# 257524San AntonioTexas78209-
Icon /Id# 257525Salt Lake CityUtah84124-

Find similar trials in Springfield, MO

By research site
Bio-Kinetic Clinical Applications, LLC· Springfield, MOIcon· San Antonio, TXIcon· Salt Lake City, UT

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