Recruiting
Phase 1

Ubrogepant

Sponsor:

AbbVie

Code:

NCT07680686

Conditions

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Ubrogepant

Ubrogepant

Study Details

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

Study ID

NCT07680686

Start date

Jul 14, 2026

Status verified date

Aug, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Ubrogepant-Part 1-Dose A

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

experimental: Ubrogepant-Part 1-Dose B

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

experimental: Ubrogepant-Part 2-Dose C

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

experimental: Ubrogepant-Part 2-Dose D

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

Interventions

Ubrogepant

IRT Oral Tablet

Ubrogepant

ODT Oral Tablet

Primary outcome measure

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

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Acpru /Id# 282727

Recruiting

Grayslake, Illinois, United States, 60030

More Information

Sponsor

AbbVie

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Healthy Volunteer
  • Ubrogepant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-10.