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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Ubrogepant; Drug: Atogepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05892757

M22-394

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Atogepant

Experimental group

Description:

Participants will receive single dose of atogepant on Day 1.

Treatment:

Drug: Atogepant

Ubrogepant

Active Comparator group

Description:

Participants will receive single dose of ubrogepant on Day 1.

Treatment:

Drug: Ubrogepant