Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. This study will assess the drug to drug interaction between atogepant and ubrogepant and assess the safety of atogepant and ubrogepant, when given alone or in combination, in adult participants with migraine. Atogepant is an investigational (unapproved) drug for the preventative treatment of migraine. Ubrogepant is a drug approved for the acute treatment of migraine. Adult participants with a history of migraine will be enrolled. Approximately, 30 participants will be enrolled in the study in multiple sites in the United States. Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination. The study duration will be 30 days with a 7 day follow period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, telephone assessments, blood tests, checking for side effects, and clinician-rated assessments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Oral; Tablet
Oral; Tablet
PPD Clinical Research Unit /ID# 227676
Orlando, Florida, United States
Bio-Kinetic Clinical Applications, LLC /ID# 227675
Springfield, Missouri, United States
Spaulding Clinical Research LLC /ID# 229505
West Bend, Wisconsin, United States
Area Under the Plasma Concentration-time Curve from Time 0 to t (AUC0-t), when Ubrogepant is Administered
Area Under the Plasma Concentration-time Curve from 0 to t (AUC0-t), when Ubrogepant is administered.
Time frame: Day 1
Area Under the Plasma Concentration-time Curve from Time 0 to t (AUC0-t), when Ubrogepant and Atogepant are Coadministered
Area Under the Plasma Concentration-time Curve from 0 to t (AUC0-t), when ubrogepant and atogepant are coadministered.
Time frame: Day 1
Area Under the Plasma Concentration-time Curve from Time 0 to Infinity (AUC0-inf), when Ubrogepant is Administered
Area Under the Plasma Concentration-time Curve from 0 to infinity (AUC0-inf), when Ubrogepant is administered.
Time frame: Day 1
Area Under the Plasma Concentration-time Curve from Time 0 to Infinity (AUC0-inf), when when Ubrogepant and Atogepant are Coadministered
Area Under the Plasma Concentration-time Curve from 0 to infinity (AUC0-inf), when ubrogepant and atogepant are coadministered.
Time frame: Day 1
Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady State (AUCtau), when Atogepant is Administered
Area Under the Plasma Concentration-time Curve during the dosing interval at steady state (AUCtau), when Atogepant is administered.
Time frame: Day 6
Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady State (AUCtau), when Ubrogepant and Atogepant are Coadministered
Area Under the Plasma Concentration-time Curve during the dosing interval at steady state (AUCtau), when ubrogepant and atogepant are coadministered.
Time frame: Day 6
Maximum Plasma Drug Concentration (Cmax) when Ubrogepant is Administered
Maximum plasma drug concentration (Cmax) when ubrogepant is administered.
Time frame: Day 1
Maximum Plasma Drug Concentration (Cmax) when Atogepant is Administered
Maximum plasma drug concentration (Cmax) when atogepant is administered.
Time frame: Day 6
Maximum Plasma Drug Concentration (Cmax) of Ubrogepant when Ubrogepant and Atogepant are Coadministered
Maximum plasma drug concentration (Cmax) of ubrogepant when ubrogepant and atogepant are coadministered.
Time frame: Day 7
Maximum Plasma Drug Concentration (Cmax) of Atogepant when Ubrogepant and Atogepant are Coadministered
Maximum plasma drug concentration (Cmax) of atogepant when ubrogepant and atogepant are coadministered.
Time frame: Day 7
Number of Participants with Abnormal Change in Physical Examinations
Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.
Time frame: Up to Day 28
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Time frame: Up to Day 28
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Time frame: Up to Day 28
Change From Baseline in Electrocardiograms (ECGs)
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Time frame: Up to Day 28
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.
Time frame: Up to Day 29
Number of Participants with Adverse Events (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to Day 37
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