Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05892757
• Other study ID #: M22-394
• Status: Completed
• Phase: Phase 1
• Start date: July 11, 2023
• Est. completion date: February 22, 2024

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 22, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Atogepant
Oral Tablet
• Ubrogepant
Oral Tablet

Locations

Country	Name	City	State
United States	Icon /Id# 257525	Salt Lake City	Utah
United States	Icon /Id# 257524	San Antonio	Texas
United States	Bio-Kinetic Clinical Applications, LLC /ID# 255452	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Day 30
Primary	Maximum Observed Plasma Concentration (Cmax) of Atogepant	Cmax of Atogepant	Up to Day 2
Primary	Maximum Observed Plasma Concentration (Cmax)of Ubrogepant	Cmax of Ubrogepant	Up to Day 2
Primary	Time to Cmax (Tmax) of Atogepant	Tmax of Atogepant	Up to Day 2
Primary	Time to Cmax (Tmax) of Ubrogepant	Tmax of Ubrogepant	Up to Day 2
Primary	Apparent Terminal Phase Elimination Rate Constant (ß) of Atogepant	Apparent terminal phase elimination rate constant of Atogepant	Up to Day 2
Primary	Apparent Terminal Phase Elimination Rate Constant (ß) of Ubrogepant	Apparent terminal phase elimination rate constant of Ubrogepant	Up to Day 2
Primary	Terminal Phase Elimination Half-life (t1/2) of Atogepant	T1/2 of Atogepant	Up to Day 2
Primary	Terminal Phase Elimination Half-life (t1/2) of Ubrogepant	T1/2 of Ubrogepant	Up to Day 2
Primary	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	Up to Day 2
Primary	AUCt of Ubrogepant	AUCt of Ubrogepant	Up to Day 2
Primary	AUC From Time 0 to the Time Infinity (AUCinf) of Atogepant	AUCinf of Atogepant	Up to Day 2
Primary	AUCinf of Ubrogepant	AUCinf of Ubrogepant	Up to Day 2
Primary	Maximum Observed Breast Milk Concentration (CMAX) of Atogepant	CMAX of Atogepant	Up to Day 2
Primary	Maximum Observed Breast Milk Concentration (CMAX) of Ubrogepant	CMAX of Ubrogepant	Up to Day 2
Primary	Time to Maximum Observed Breast Milk Concentration (TMAX) of Atogepant	TMAX of Atogepant	Up to Day 2
Primary	Time to Maximum Observed Breast Milk Concentration (TMAX) of Ubrogepant	TMAX of Ubrogepant	Up to Day 2
Primary	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	Up to Day 2
Primary	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	Up to Day 2
Primary	Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Atogepant	AUCINF of Atogepant	Up to Day 2
Primary	Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Ubrogepant	AUCINF of Ubrogepant	Up to Day 2

External Links

•   Related Info