Healthy VolunteerPhase 1NCT07680686

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

A Phase 1 study testing Ubrogepant in people with Healthy Volunteer, run by AbbVie at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: Ubrogepant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 14 Jul 2026to Oct 2026
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Acpru /Id# 282727
Grayslake, Illinois, 60030

Other trials in United States

About this study

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

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

Conditions: Healthy Volunteer
Being tested: Ubrogepant
Keywords: Healthy Volunteer, Ubrogepant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UbrogepantDrug
IRT Oral Tablet
UbrogepantDrug
ODT Oral Tablet

Study groups in NCT07680686
Study group	Role	What they receive
Ubrogepant-Part 1-Dose A	Experimental	Participants will receive a single oral dose A of ubrogepant on Day 1 under fasting conditions. Receives: Drug: Ubrogepant
Ubrogepant-Part 1-Dose B	Experimental	Participants will receive a single oral dose B of ubrogepant on Day 1 under fasting conditions. Receives: Drug: Ubrogepant
Ubrogepant-Part 2-Dose C	Experimental	Participants will receive a single oral dose C of ubrogepant on Day 1 under fasting conditions. Receives: Drug: Ubrogepant
Ubrogepant-Part 2-Dose D	Experimental	Participants will receive a single oral dose D of ubrogepant on Day 1 under fed conditions. Receives: Drug: Ubrogepant

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: Up to approximately 3 days
AUC From Time 0 to the Time Infinity (AUCinf) of Ubrogepant
AUCinf of Ubrogepant
Measured: Up to approximately 3 days
Maximum Observed Plasma Concentration (Cmax) of Ubrogepant
Cmax of Ubrogepant
Measured: 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
Measured: Up to approximately 3 days
Time to maximum observed plasma concentration (Tmax) of Ubrogepant
Tmax of Ubrogepant
Measured: Up to approximately 3 days
Apparent terminal phase elimination constant (λz) of Ubrogepant
λz of Ubrogepant
Measured: Up to approximately 3 days
Terminal phase elimination half-life (t1/2) of Ubrogepant
t1/2 of Ubrogepant
Measured: Up to approximately 3 days
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Ubrogepant
CL/F of Ubrogepant
Measured: Up to approximately 3 days
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Ubrogepant
Vz/F of Ubrogepant
Measured: Up to approximately 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 2026Oct 2026

First posted2 Jul 2026
Study start14 Jul 2026
Primary completionOct 2026 (estimated)
Study completionOct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07680686
Sponsor's protocol ID: M26-480
Status last verified: Oct 2026
First submitted: 26 Jun 2026
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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