drugset / Trial / NCT05892757
Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers
Non-randomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2023-07-11
- Primary completion
- 2024-02-22
- Completion
- 2024-02-22
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atogepant | Small molecule | 60 mg | Oral |
| Comparator | Ubrogepant | Small molecule | 100 mg | Oral |
Indications
No indication recorded.