Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, Atogepant, Ubrogepant
Brief 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.
Interventions
DRUGAtogepant
Oral Tablet
DRUGUbrogepant
Oral Tablet
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events | 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 | Up to Day 2 | Cmax of Atogepant |
| Maximum Observed Plasma Concentration (Cmax)of Ubrogepant | Up to Day 2 | Cmax of Ubrogepant |
| Time to Cmax (Tmax) of Atogepant | Up to Day 2 | Tmax of Atogepant |
| Time to Cmax (Tmax) of Ubrogepant | Up to Day 2 | Tmax of Ubrogepant |
| Apparent Terminal Phase Elimination Rate Constant (β) of Atogepant | Up to Day 2 | Apparent terminal phase elimination rate constant of Atogepant |
| Apparent Terminal Phase Elimination Rate Constant (β) of Ubrogepant | Up to Day 2 | Apparent terminal phase elimination rate constant of Ubrogepant |
| Terminal Phase Elimination Half-life (t1/2) of Atogepant | Up to Day 2 | T1/2 of Atogepant |
| Terminal Phase Elimination Half-life (t1/2) of Ubrogepant | 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 | Up to Day 2 | AUCt of Atogepant |
| AUCt of Ubrogepant | Up to Day 2 | AUCt of Ubrogepant |
| AUC From Time 0 to the Time Infinity (AUCinf) of Atogepant | Up to Day 2 | AUCinf of Atogepant |
| AUCinf of Ubrogepant | Up to Day 2 | AUCinf of Ubrogepant |
| Maximum Observed Breast Milk Concentration (CMAX) of Atogepant | Up to Day 2 | CMAX of Atogepant |
| Maximum Observed Breast Milk Concentration (CMAX) of Ubrogepant | Up to Day 2 | CMAX of Ubrogepant |
| Time to Maximum Observed Breast Milk Concentration (TMAX) of Atogepant | Up to Day 2 | TMAX of Atogepant |
| Time to Maximum Observed Breast Milk Concentration (TMAX) of Ubrogepant | 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 | 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 | Up to Day 2 | AUCLST of Ubrogepant |
| Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Atogepant | Up to Day 2 | AUCINF of Atogepant |
| Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Ubrogepant | Up to Day 2 | AUCINF of Ubrogepant |
Countries
United States
Outcome results
None listed