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

Phase 1RecruitingNCT07680686

AbbVie52 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteer

Interventions

UbrogepantDRUG

IRT Oral Tablet

UbrogepantDRUG

ODT Oral Tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Acpru /Id# 282727

Grayslake, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

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.

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

AUCt of Ubrogepant