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

NCT07680686 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: M26-480
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; Ubrogepant

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (4)

Ubrogepant-Part 1-Dose A

EXPERIMENTAL

Participants will receive a single oral dose A of ubrogepant on Day 1 under fasting conditions.

Drug: Ubrogepant

Ubrogepant-Part 1-Dose B

EXPERIMENTAL

Participants will receive a single oral dose B of ubrogepant on Day 1 under fasting conditions.

Drug: Ubrogepant

Ubrogepant-Part 2-Dose C

EXPERIMENTAL

Participants will receive a single oral dose C of ubrogepant on Day 1 under fasting conditions.

Drug: Ubrogepant

Ubrogepant-Part 2-Dose D

EXPERIMENTAL

Participants will receive a single oral dose D of ubrogepant on Day 1 under fed conditions.

Drug: Ubrogepant

Interventions

Ubrogepant DRUG

IRT Oral Tablet

Ubrogepant-Part 1-Dose B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Interventions

ubrogepant

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share