Clinical Trials in the USA / NCT07680686
Active, not recruiting
Phase 1
Study to Assess How Different Oral Formulations of Ubrogepant Move Through the Body in Healthy Adult Participants
NCT07680686 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Healthy Volunteer
Investigational drug(s) / intervention(s)
Ubrogepant: IRT Oral Tablet
Ubrogepant: ODT Oral Tablet
Study summary
This study will assess how different oral formulations of ubrogepant move through the body in healthy adult participants under fasting and fed conditions.
Eligibility
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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Acpru /Id# 282727 | Grayslake | Illinois |
On this site
📄 Ubrelvy (ubrogepant) drug profile →More AbbVie trials in the USA
Other trials for the same condition
A Study to Evaluate How Multiple Doses of Itraconazole Interacts With Nacresertib in Healthy Adult Participants
Active, not recruiting
Comparison of Pharmacokinetic Responses to Three Ketone Esters
Active, not recruiting
Official registry record
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.
View NCT07680686 on ClinicalTrials.gov ↗ ← All trials in the USA