Study to Assess How Different Oral Formulations of Ubrogepant Move Through the Body in Healthy Adult Participants

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07680686

Enrollment

Registered

2026-07-02

Start date

2026-07-14

Completion date

2026-10-01

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer, Ubrogepant

Brief summary

This study will assess how different oral formulations of ubrogepant move through the body in healthy adult participants under fasting and fed conditions.

Interventions

DRUGUbrogepant

IRT Oral Tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Contacts

CONTACTABBVIE CALL CENTER

abbvieclinicaltrials@abbvie.com844-663-3742

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026