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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Atogepant
* Drug: Ubrogepant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atogepant<br>Participants will receive single dose of atogepant on Day 1. | Drug: Atogepant<br>* Oral Tablet<br>* Other names: QULIPTA;|
| Active Comparator: Ubrogepant<br>Participants will receive single dose of ubrogepant on Day 1. | Drug: Ubrogepant<br>* Oral Tablet<br>* Other names: UBRELVY;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, Atogepant, Ubrogepant