Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers
- Registration Number
- NCT05892757
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
- 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.
- Prior exposure to ubrogepant or atogepant within the past 30 days.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atogepant Atogepant Participants will receive single dose of atogepant on Day 1. Ubrogepant Ubrogepant Participants will receive single dose of ubrogepant on Day 1.
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of Atogepant Up to Day 2 Cmax of Atogepant
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 Ubrogepant Up to Day 2 Cmax 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
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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Bio-Kinetic Clinical Applications, LLC /ID# 255452
🇺🇸Springfield, Missouri, United States
Icon /Id# 257524
🇺🇸San Antonio, Texas, United States
Icon /Id# 257525
🇺🇸Salt Lake City, Utah, United States
Bio-Kinetic Clinical Applications, LLC /ID# 255452🇺🇸Springfield, Missouri, United States