Study to Assess How Different Oral Formulations of Ubrogepant Move Through the Body in Healthy Adult Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ubrogepant, Ubrogepant.
- Who it may be relevant to
- Registry conditions: Healthy Volunteer. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Two-Part, Phase 1, Open-Label, Randomized Study to Evaluate the Relative Bioavailability (Versus Immediate Release Tablet) and Food Effect of a New Orally Disintegrating Tablet Formulation of Ubrogepant in Healthy Volunteers
Overview
This study will assess how different oral formulations of ubrogepant move through the body in healthy adult participants under fasting and fed conditions.
Interventions
- Drug Ubrogepant
IRT Oral Tablet - Drug Ubrogepant
ODT Oral Tablet
Primary outcome measures
- Number of Participants Experiencing Adverse Events [Time frame: Up to approximately 33 days]
- Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of Ubrogepant [Time frame: Up to approximately 3 days]
- AUC From Time 0 to the Time Infinity (AUCinf) of Ubrogepant [Time frame: Up to approximately 3 days]
- Maximum Observed Plasma Concentration (Cmax) of Ubrogepant [Time frame: Up to approximately 3 days]
- Time lag between dosing and drug to appear in systemic circulation following extravascular administration (Tlag) of Ubrogepant [Time frame: Up to approximately 3 days]
- Time to maximum observed plasma concentration (Tmax) of Ubrogepant [Time frame: Up to approximately 3 days]
- Apparent terminal phase elimination constant (λz) of Ubrogepant [Time frame: Up to approximately 3 days]
- Terminal phase elimination half-life (t1/2) of Ubrogepant [Time frame: Up to approximately 3 days]
- Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Ubrogepant [Time frame: Up to approximately 3 days]
- Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Ubrogepant [Time frame: Up to approximately 3 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07680686 · M26-480