Clinical trial NCT05892757: Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Atogepant
Ubrogepant
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-06-07
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to Day 30
measure: Maximum Observed Plasma Concentration (Cmax) of Atogepant
timeFrame: Up to Day 2
measure: Maximum Observed Plasma Concentration (Cmax)of Ubrogepant
timeFrame: Up to Day 2
measure: Time to Cmax (Tmax) of Atogepant
timeFrame: Up to Day 2
measure: Time to Cmax (Tmax) of Ubrogepant
timeFrame: Up to Day 2
measure: Apparent Terminal Phase Elimination Rate Constant (β) of Atogepant
timeFrame: Up to Day 2
measure: Apparent Terminal Phase Elimination Rate Constant (β) of Ubrogepant
timeFrame: Up to Day 2
measure: Terminal Phase Elimination Half-life (t1/2) of Atogepant
timeFrame: Up to Day 2
measure: Terminal Phase Elimination Half-life (t1/2) of Ubrogepant
timeFrame: Up to Day 2
measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Atogepant
timeFrame: Up to Day 2
measure: AUCt of Ubrogepant
timeFrame: Up to Day 2
measure: AUC From Time 0 to the Time Infinity (AUCinf) of Atogepant
timeFrame: Up to Day 2
measure: AUCinf of Ubrogepant
timeFrame: Up to Day 2
measure: Maximum Observed Breast Milk Concentration (CMAX) of Atogepant
timeFrame: Up to Day 2
measure: Maximum Observed Breast Milk Concentration (CMAX) of Ubrogepant
timeFrame: Up to Day 2
measure: Time to Maximum Observed Breast Milk Concentration (TMAX) of Atogepant
timeFrame: Up to Day 2
measure: Time to Maximum Observed Breast Milk Concentration (TMAX) of Ubrogepant
timeFrame: Up to Day 2
measure: Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCLST) of Atogepant
timeFrame: Up to Day 2
measure: Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCLST) of Ubrogepant
timeFrame: Up to Day 2
measure: Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Atogepant
timeFrame: Up to Day 2
measure: Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Ubrogepant
timeFrame: Up to Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLC /ID# 255452
state: Missouri
city: San Antonio
country: United States
facility: Icon /Id# 257524
state: Texas
city: Salt Lake City
country: United States
facility: Icon /Id# 257525
state: Utah
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: