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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atogepant | Experimental | Participants will receive single dose of atogepant on Day 1. |
|
| Ubrogepant | Active Comparator | Participants will receive single dose of ubrogepant on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant | Drug | Oral Tablet |
|
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Prior exposure to ubrogepant or atogepant within the past 30 days.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bio-Kinetic Clinical Applications, LLC /ID# 255452 | Springfield | Missouri | 65802 | United States | ||
| Icon /Id# 257524 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40455369 | Derived | 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. | |
| 40391560 | Derived | Boinpally RR, Smith JH, Cohen E, Trugman JM. Milk and plasma pharmacokinetics of single-dose ubrogepant in healthy lactating women. Headache. 2025 Jul-Aug;65(7):1190-1197. doi: 10.1111/head.14960. Epub 2025 May 20. |
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| Ubrogepant |
| Drug |
Oral Tablet |
|
|
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 |
| San Antonio |
| Texas |
| 78209 |
| United States |
| Icon /Id# 257525 | Salt Lake City | Utah | 84124 | United States |
| ID | Term |
|---|---|
| C000718987 | atogepant |
| C000615620 | ubrogepant |
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