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

NCT05892757 | Completed Phase 1

• 1 other identifier: M22-394
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Atogepant; Ubrogepant

Outcome Measures

Primary Outcomes (21)

• 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

Study Arms (2)

Atogepant

EXPERIMENTAL

Participants will receive single dose of atogepant on Day 1.

Drug: Atogepant

Ubrogepant

ACTIVE COMPARATOR

Participants will receive single dose of ubrogepant on Day 1.

Drug: Ubrogepant

Interventions

Atogepant DRUG

Oral Tablet

Also known as: QULIPTA

Atogepant

Ubrogepant DRUG

Oral Tablet

Also known as: UBRELVY

Ubrogepant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- Prior exposure to ubrogepant or atogepant within the past 30 days.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

Bio-Kinetic Clinical Applications, LLC /ID# 255452

Springfield, Missouri, 65802, United States

Location

Icon /Id# 257524

San Antonio, Texas, 78209, United States

Location

Icon /Id# 257525

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

• Boinpally RR, Smith JH, De Abreu Ferreira RL, Trugman JM. Pharmacokinetics of Atogepant in Healthy Lactating Female Participants: Results from a Phase 1 Lactation Study. Neurol Ther. 2025 Aug;14(4):1461-1473. doi: 10.1007/s40120-025-00772-4. Epub 2025 Jun 2.

  PMID: 40455369 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

atogepant; ubrogepant

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 7, 2023
• Study Start: July 11, 2023
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)