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Completed

NCT Number: NCT05892757

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Bio-Kinetic Clinical Applications, LLC /ID# 255452, Springfield, Missouri, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atogepant

Drug

Oral Tablet

Other names: QULIPTA

Ubrogepant

Drug

Oral Tablet

Other names: UBRELVY

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: Up to Day 30

    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.

  2. Maximum Observed Plasma Concentration (Cmax) of Atogepant

    Time frame: Up to Day 2

    Cmax of Atogepant

  3. Maximum Observed Plasma Concentration (Cmax)of Ubrogepant

    Time frame: Up to Day 2

    Cmax of Ubrogepant

  4. Time to Cmax (Tmax) of Atogepant

    Time frame: Up to Day 2

    Tmax of Atogepant

  5. Time to Cmax (Tmax) of Ubrogepant

    Time frame: Up to Day 2

    Tmax of Ubrogepant

  6. Apparent Terminal Phase Elimination Rate Constant (β) of Atogepant

    Time frame: Up to Day 2

    Apparent terminal phase elimination rate constant of Atogepant

  7. Apparent Terminal Phase Elimination Rate Constant (β) of Ubrogepant

    Time frame: Up to Day 2

    Apparent terminal phase elimination rate constant of Ubrogepant

  8. Terminal Phase Elimination Half-life (t1/2) of Atogepant

    Time frame: Up to Day 2

    T1/2 of Atogepant

  9. Terminal Phase Elimination Half-life (t1/2) of Ubrogepant

    Time frame: Up to Day 2

    T1/2 of Ubrogepant

  10. Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Atogepant

    Time frame: Up to Day 2

    AUCt of Atogepant

  11. AUCt of Ubrogepant

    Time frame: Up to Day 2

    AUCt of Ubrogepant

  12. AUC From Time 0 to the Time Infinity (AUCinf) of Atogepant

    Time frame: Up to Day 2

    AUCinf of Atogepant

  13. AUCinf of Ubrogepant

    Time frame: Up to Day 2

    AUCinf of Ubrogepant

  14. Maximum Observed Breast Milk Concentration (CMAX) of Atogepant

    Time frame: Up to Day 2

    CMAX of Atogepant

  15. Maximum Observed Breast Milk Concentration (CMAX) of Ubrogepant

    Time frame: Up to Day 2

    CMAX of Ubrogepant

  16. Time to Maximum Observed Breast Milk Concentration (TMAX) of Atogepant

    Time frame: Up to Day 2

    TMAX of Atogepant

  17. Time to Maximum Observed Breast Milk Concentration (TMAX) of Ubrogepant

    Time frame: Up to Day 2

    TMAX of Ubrogepant

  18. Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCLST) of Atogepant

    Time frame: Up to Day 2

    AUCLST of Atogepant

  19. Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCLST) of Ubrogepant

    Time frame: Up to Day 2

    AUCLST of Ubrogepant

  20. Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Atogepant

    Time frame: Up to Day 2

    AUCINF of Atogepant

  21. Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Ubrogepant

    Time frame: Up to Day 2

    AUCINF of Ubrogepant

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2023
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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