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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Ubrogepant; Drug: Ubrogepant

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ubrogepant-Part 1-Dose A; Participants will receive a single oral dose A of ubrogepant on Day 1 under fasting conditions.	Drug: Ubrogepant; IRT Oral Tablet; Drug: Ubrogepant; ODT Oral Tablet
Experimental: Ubrogepant-Part 1-Dose B; Participants will receive a single oral dose B of ubrogepant on Day 1 under fasting conditions.	Drug: Ubrogepant; IRT Oral Tablet; Drug: Ubrogepant; ODT Oral Tablet
Experimental: Ubrogepant-Part 2-Dose C; Participants will receive a single oral dose C of ubrogepant on Day 1 under fasting conditions.	Drug: Ubrogepant; IRT Oral Tablet; Drug: Ubrogepant; ODT Oral Tablet
Experimental: Ubrogepant-Part 2-Dose D; Participants will receive a single oral dose D of ubrogepant on Day 1 under fed conditions.	Drug: Ubrogepant; IRT Oral Tablet; Drug: Ubrogepant; ODT Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Adverse Events	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.	Up to approximately 33 days
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of Ubrogepant	AUCt of Ubrogepant	Up to approximately 3 days
AUC From Time 0 to the Time Infinity (AUCinf) of Ubrogepant	AUCinf of Ubrogepant	Up to approximately 3 days
Maximum Observed Plasma Concentration (Cmax) of Ubrogepant	Cmax of Ubrogepant	Up to approximately 3 days
Time lag between dosing and drug to appear in systemic circulation following extravascular administration (Tlag) of Ubrogepant	Tlag of Ubrogepant	Up to approximately 3 days
Time to maximum observed plasma concentration (Tmax) of Ubrogepant	Tmax of Ubrogepant	Up to approximately 3 days
Apparent terminal phase elimination constant (λz) of Ubrogepant	λz of Ubrogepant	Up to approximately 3 days
Terminal phase elimination half-life (t1/2) of Ubrogepant	t1/2 of Ubrogepant	Up to approximately 3 days
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Ubrogepant	CL/F of Ubrogepant	Up to approximately 3 days
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Ubrogepant	Vz/F of Ubrogepant	Up to approximately 3 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteer; Ubrogepant
• Additional Relevant MeSH Terms: ubrogepant
• Other Study ID Numbers: M26-480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No