This study will assess how different oral formulations of ubrogepant move through the body in healthy adult participants under fasting and fed conditions.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
Exclusion Criteria:
* History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, neurologic, or psychiatric disease or disorder, history of Raynaud's Phenomenon, or any uncontrolled medical illness.
* History of any clinically significant sensitivity or allergy to any medication or food.
Primary outcome measure(s)
Number of Participants Experiencing Adverse Events — Up to approximately 33 days 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.
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of Ubrogepant — Up to approximately 3 days AUCt of Ubrogepant
AUC From Time 0 to the Time Infinity (AUCinf) of Ubrogepant — Up to approximately 3 days AUCinf of Ubrogepant
Maximum Observed Plasma Concentration (Cmax) of Ubrogepant — Up to approximately 3 days Cmax of Ubrogepant
Time lag between dosing and drug to appear in systemic circulation following extravascular administration (Tlag) of Ubrogepant — Up to approximately 3 days Tlag of Ubrogepant
Time to maximum observed plasma concentration (Tmax) of Ubrogepant — Up to approximately 3 days Tmax of Ubrogepant
Apparent terminal phase elimination constant (λz) of Ubrogepant — Up to approximately 3 days λz of Ubrogepant
Terminal phase elimination half-life (t1/2) of Ubrogepant — Up to approximately 3 days t1/2 of Ubrogepant
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Ubrogepant — Up to approximately 3 days CL/F of Ubrogepant
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Ubrogepant — Up to approximately 3 days Vz/F of Ubrogepant
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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