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NCT Number: NCT07680686

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

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

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ubrogepant

Drug

IRT Oral Tablet

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: 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.

  2. 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

    AUCt of Ubrogepant

  3. AUC From Time 0 to the Time Infinity (AUCinf) of Ubrogepant

    Time frame: Up to approximately 3 days

    AUCinf of Ubrogepant

  4. Maximum Observed Plasma Concentration (Cmax) of Ubrogepant

    Time frame: Up to approximately 3 days

    Cmax of Ubrogepant

  5. Time lag between dosing and drug to appear in systemic circulation following extravascular administration (Tlag) of Ubrogepant

    Time frame: Up to approximately 3 days

    Tlag of Ubrogepant

  6. Time to maximum observed plasma concentration (Tmax) of Ubrogepant

    Time frame: Up to approximately 3 days

    Tmax of Ubrogepant

  7. Apparent terminal phase elimination constant (λz) of Ubrogepant

    Time frame: Up to approximately 3 days

    λz of Ubrogepant

  8. Terminal phase elimination half-life (t1/2) of Ubrogepant

    Time frame: Up to approximately 3 days

    t1/2 of Ubrogepant

  9. Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Ubrogepant

    Time frame: Up to approximately 3 days

    CL/F of Ubrogepant

  10. Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Ubrogepant

    Time frame: Up to approximately 3 days

    Vz/F of Ubrogepant

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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