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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ubrogepant-Part 1-Dose A 		Participants will receive a single oral dose A of ubrogepant on Day 1 under fasting conditions.
  • 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
Experimental
Ubrogepant-Part 2-Dose C 		Participants will receive a single oral dose C of ubrogepant on Day 1 under fasting conditions.
  • 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
    ODT Oral Tablet

Recruiting Locations

Acpru /Id# 282727
Grayslake, Illinois 60030

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.