Clinical trial

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

Name

M22-394

Description

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.

Trial arms

Trial start

2023-07-11

Estimated PCD

2024-02-22

Trial end

2024-02-22

Status

Completed

Phase

Early phase I

Treatment

Atogepant

Oral Tablet

Arms:

Atogepant

Other names:

QULIPTA

Ubrogepant

Oral Tablet

Arms:

Ubrogepant

Other names:

UBRELVY

Size

Primary endpoint

Number of Participants Experiencing Adverse Events

Up to Day 30

Maximum Observed Plasma Concentration (Cmax) of Atogepant

Up to Day 2

Maximum Observed Plasma Concentration (Cmax)of Ubrogepant

Up to Day 2

Time to Cmax (Tmax) of Atogepant

Up to Day 2

Time to Cmax (Tmax) of Ubrogepant

Up to Day 2

Apparent Terminal Phase Elimination Rate Constant (β) of Atogepant

Up to Day 2

Apparent Terminal Phase Elimination Rate Constant (β) of Ubrogepant

Up to Day 2

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

Up to Day 2

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

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

Up to Day 2

AUCt of Ubrogepant

Up to Day 2

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

Up to Day 2

AUCinf of Ubrogepant

Up to Day 2

Maximum Observed Breast Milk Concentration (CMAX) of Atogepant

Up to Day 2

Maximum Observed Breast Milk Concentration (CMAX) of Ubrogepant

Up to Day 2

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

Up to Day 2

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

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

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

Up to Day 2

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

Up to Day 2

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

Up to Day 2

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

Updated at

2024-03-12

1 organization

2 products

1 indication

Organization

AbbVie

Product

Ubrogepant

Indication

Healthy Control Participants

Product

Atogepant