Healthy VolunteersPhase 1NCT05892757
Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers
A Phase 1 study testing Atogepant and Ubrogepant in people with Healthy Volunteers, run by AbbVie at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Atogepant and Ubrogepant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jul 2023to 22 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Prior exposure to ubrogepant or atogepant within the past 30 days.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Icon /Id# 257525
Salt Lake City, Utah, 84124
Icon /Id# 257524
San Antonio, Texas, 78209
Bio-Kinetic Clinical Applications, LLC /ID# 255452
Springfield, Missouri, 65802
About this study
Official 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
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
- Being tested
- Atogepant, Ubrogepant
- Keywords
- Healthy Volunteers, Atogepant, Ubrogepant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtogepantDrug
Also called QULIPTA
Oral Tablet
UbrogepantDrug
Also called UBRELVY
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Atogepant | Experimental | Participants will receive single dose of atogepant on Day 1. Receives: Drug: Atogepant |
| Ubrogepant | Active comparator | Participants will receive single dose of ubrogepant on Day 1. Receives: Drug: Ubrogepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 30
Maximum Observed Plasma Concentration (Cmax) of Atogepant
Cmax of Atogepant
Measured: Up to Day 2
Maximum Observed Plasma Concentration (Cmax)of Ubrogepant
Cmax of Ubrogepant
Measured: Up to Day 2
Time to Cmax (Tmax) of Atogepant
Tmax of Atogepant
Measured: Up to Day 2
Time to Cmax (Tmax) of Ubrogepant
Tmax of Ubrogepant
Measured: Up to Day 2
Apparent Terminal Phase Elimination Rate Constant (β) of Atogepant
Apparent terminal phase elimination rate constant of Atogepant
Measured: Up to Day 2
Apparent Terminal Phase Elimination Rate Constant (β) of Ubrogepant
Apparent terminal phase elimination rate constant of Ubrogepant
Measured: Up to Day 2
Terminal Phase Elimination Half-life (t1/2) of Atogepant
T1/2 of Atogepant
Measured: Up to Day 2
Terminal Phase Elimination Half-life (t1/2) of Ubrogepant
T1/2 of Ubrogepant
Measured: 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
Measured: Up to Day 2
AUCt of Ubrogepant
AUCt of Ubrogepant
Measured: Up to Day 2
AUC From Time 0 to the Time Infinity (AUCinf) of Atogepant
AUCinf of Atogepant
Measured: Up to Day 2
AUCinf of Ubrogepant
AUCinf of Ubrogepant
Measured: Up to Day 2
Maximum Observed Breast Milk Concentration (CMAX) of Atogepant
CMAX of Atogepant
Measured: Up to Day 2
Maximum Observed Breast Milk Concentration (CMAX) of Ubrogepant
CMAX of Ubrogepant
Measured: Up to Day 2
Time to Maximum Observed Breast Milk Concentration (TMAX) of Atogepant
TMAX of Atogepant
Measured: Up to Day 2
Time to Maximum Observed Breast Milk Concentration (TMAX) of Ubrogepant
TMAX of Ubrogepant
Measured: 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
Measured: 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
Measured: Up to Day 2
Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Atogepant
AUCINF of Atogepant
Measured: Up to Day 2
Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Ubrogepant
AUCINF of Ubrogepant
Measured: Up to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start11 Jul 2023
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892757
- Sponsor's protocol ID
- M22-394
- Status last verified
- Mar 2024
- First submitted
- 30 May 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40455369Boinpally 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.
PubMed 40391560
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05892757
- Acronym / sponsor ID
- M22-394
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, Atogepant, Ubrogepant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atogepant | Experimental | Drug: AtogepantParticipants will receive single dose of atogepant on Day 1. |
| Ubrogepant | Active comparator | Drug: UbrogepantParticipants will receive single dose of ubrogepant on Day 1. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Prior exposure to ubrogepant or atogepant within the past 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtogepantAlso: QULIPTAOral Tablet | Drug | Atogepant |
| UbrogepantAlso: UBRELVYOral Tablet | Drug | Ubrogepant |
Primary outcome
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.
Maximum Observed Plasma Concentration (Cmax) of Atogepant
Time frame: Up to Day 2
Cmax of Atogepant
Maximum Observed Plasma Concentration (Cmax)of Ubrogepant
Time frame: Up to Day 2
Cmax of Ubrogepant
Time to Cmax (Tmax) of Atogepant
Time frame: Up to Day 2
Tmax of Atogepant
Time to Cmax (Tmax) of Ubrogepant
Time frame: Up to Day 2
Tmax of Ubrogepant
Apparent Terminal Phase Elimination Rate Constant (β) of Atogepant
Time frame: Up to Day 2
Apparent terminal phase elimination rate constant of Atogepant
Apparent Terminal Phase Elimination Rate Constant (β) of Ubrogepant
Time frame: Up to Day 2
Apparent terminal phase elimination rate constant of Ubrogepant
Terminal Phase Elimination Half-life (t1/2) of Atogepant
Time frame: Up to Day 2
T1/2 of Atogepant
Terminal Phase Elimination Half-life (t1/2) of Ubrogepant
Time frame: Up to Day 2
T1/2 of Ubrogepant
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
AUCt of Ubrogepant
Time frame: Up to Day 2
AUCt of Ubrogepant
AUC From Time 0 to the Time Infinity (AUCinf) of Atogepant
Time frame: Up to Day 2
AUCinf of Atogepant
AUCinf of Ubrogepant
Time frame: Up to Day 2
AUCinf of Ubrogepant
Maximum Observed Breast Milk Concentration (CMAX) of Atogepant
Time frame: Up to Day 2
CMAX of Atogepant
Maximum Observed Breast Milk Concentration (CMAX) of Ubrogepant
Time frame: Up to Day 2
CMAX of Ubrogepant
Time to Maximum Observed Breast Milk Concentration (TMAX) of Atogepant
Time frame: Up to Day 2
TMAX of Atogepant
Time to Maximum Observed Breast Milk Concentration (TMAX) of Ubrogepant
Time frame: Up to Day 2
TMAX of Ubrogepant
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 40455369Boinpally 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.
- Derived from this study: PubMed 40391560Boinpally 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atogepant and Ubrogepant in people with Healthy Volunteers, run by AbbVie at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Adverse Events (time frame: Up to Day 30). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05892757, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.