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

A Phase 1 Lactation Study in Healthy Adult Lactating Female Subjects One to Six Months Post-Partum to Evaluate the Pharmacokinetics and Safety of Ubrogepant and Atogepant

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Ubrogepant; Drug: Atogepant

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Springfield, Missouri, United States, 65802
      • Bio-Kinetic Clinical Applications, LLC /ID# 255452
  • Texas
    • San Antonio, Texas, United States, 78209
      • Icon /Id# 257524
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Icon /Id# 257525

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atogepant; Participants will receive single dose of atogepant on Day 1.	Drug: Atogepant; Oral Tablet; Other Names: QULIPTA
Active Comparator: Ubrogepant; Participants will receive single dose of ubrogepant on Day 1.	Drug: Ubrogepant; Oral Tablet; Other Names: UBRELVY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Adverse Events	An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to Day 30
Maximum Observed Plasma Concentration (Cmax) of Atogepant	Cmax of Atogepant	Up to Day 2
Maximum Observed Plasma Concentration (Cmax)of Ubrogepant	Cmax of Ubrogepant	Up to Day 2
Time to Cmax (Tmax) of Atogepant	Tmax of Atogepant	Up to Day 2
Time to Cmax (Tmax) of Ubrogepant	Tmax of Ubrogepant	Up to Day 2
Apparent Terminal Phase Elimination Rate Constant (β) of Atogepant	Apparent terminal phase elimination rate constant of Atogepant	Up to Day 2
Apparent Terminal Phase Elimination Rate Constant (β) of Ubrogepant	Apparent terminal phase elimination rate constant of Ubrogepant	Up to Day 2
Terminal Phase Elimination Half-life (t1/2) of Atogepant	T1/2 of Atogepant	Up to Day 2
Terminal Phase Elimination Half-life (t1/2) of Ubrogepant	T1/2 of Ubrogepant	Up to Day 2
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Atogepant	AUCt of Atogepant	Up to Day 2
AUCt of Ubrogepant	AUCt of Ubrogepant	Up to Day 2
AUC From Time 0 to the Time Infinity (AUCinf) of Atogepant	AUCinf of Atogepant	Up to Day 2
AUCinf of Ubrogepant	AUCinf of Ubrogepant	Up to Day 2
Maximum Observed Breast Milk Concentration (CMAX) of Atogepant	CMAX of Atogepant	Up to Day 2
Maximum Observed Breast Milk Concentration (CMAX) of Ubrogepant	CMAX of Ubrogepant	Up to Day 2
Time to Maximum Observed Breast Milk Concentration (TMAX) of Atogepant	TMAX of Atogepant	Up to Day 2
Time to Maximum Observed Breast Milk Concentration (TMAX) of Ubrogepant	TMAX of Ubrogepant	Up to Day 2
Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCLST) of Atogepant	AUCLST of Atogepant	Up to Day 2
Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCLST) of Ubrogepant	AUCLST of Ubrogepant	Up to Day 2
Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Atogepant	AUCINF of Atogepant	Up to Day 2
Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Ubrogepant	AUCINF of Ubrogepant	Up to Day 2

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Actual): February 22, 2024
• Study Completion (Actual): February 22, 2024

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Ubrogepant; Atogepant
• Other Study ID Numbers: M22-394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No