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

AbbVie24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Atogepant

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

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.

Time frame: Up to Day 30

Maximum Observed Plasma Concentration (Cmax) of Atogepant

Cmax of Atogepant

Time frame: Up to Day 2

Maximum Observed Plasma Concentration (Cmax)of Ubrogepant

Cmax of Ubrogepant

Time frame: Up to Day 2

Time to Cmax (Tmax) of Atogepant

Tmax of Atogepant

Time frame: Up to Day 2

Time to Cmax (Tmax) of Ubrogepant

Tmax of Ubrogepant

Time frame: Up to Day 2

Apparent Terminal Phase Elimination Rate Constant (β) of Atogepant

Apparent terminal phase elimination rate constant of Atogepant

Time frame: Up to Day 2

Apparent Terminal Phase Elimination Rate Constant (β) of Ubrogepant

Apparent terminal phase elimination rate constant of Ubrogepant

Time frame: Up to Day 2

Terminal Phase Elimination Half-life (t1/2) of Atogepant

T1/2 of Atogepant

Time frame: Up to Day 2

Terminal Phase Elimination Half-life (t1/2) of Ubrogepant

T1/2 of Ubrogepant

Time frame: 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

Time frame: Up to Day 2

AUCt of Ubrogepant

Time frame: Up to Day 2

AUC From Time 0 to the Time Infinity (AUCinf) of Atogepant

AUCinf of Atogepant

Time frame: Up to Day 2

AUCinf of Ubrogepant

Time frame: Up to Day 2

Maximum Observed Breast Milk Concentration (CMAX) of Atogepant

CMAX of Atogepant

Time frame: Up to Day 2

Maximum Observed Breast Milk Concentration (CMAX) of Ubrogepant

CMAX of Ubrogepant

Time frame: Up to Day 2

Time to Maximum Observed Breast Milk Concentration (TMAX) of Atogepant

TMAX of Atogepant

Time frame: Up to Day 2

Time to Maximum Observed Breast Milk Concentration (TMAX) of Ubrogepant

TMAX of Ubrogepant

Time frame: 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

Time frame: 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

Time frame: Up to Day 2

Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Atogepant

AUCINF of Atogepant

Time frame: Up to Day 2

Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Ubrogepant

AUCINF of Ubrogepant

Time frame: Up to Day 2