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A Study to Assess the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Adult Volunteers

NCT ID: NCT06078202

Last Updated: 2024-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-01-31

Brief Summary

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The purpose of this study is to evaluate the relative bioavailability of three immediate-release table formulations of ABBV-903 under fasting conditions in healthy volunteers, and to evaluate the effect of food on the pharmacokinetics of three immediate-release table formulations of ABBV-903.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1, Sequence A

Participants will receive 1 dose of ABBV-903.

Group Type EXPERIMENTAL

ABBV-903

Intervention Type DRUG

Tablet; oral

Part 1, Sequence B

Participants will receive 1 dose of ABBV-903.

Group Type EXPERIMENTAL

ABBV-903

Intervention Type DRUG

Tablet; oral

Part 1, Sequence C

Participants will receive 1 dose of ABBV-903.

Group Type EXPERIMENTAL

ABBV-903

Intervention Type DRUG

Tablet; oral

Part 2, Sequence A

Participants will receive 1 dose of ABBV-903.

Group Type EXPERIMENTAL

ABBV-903

Intervention Type DRUG

Tablet; oral

Part 2, Sequence B

Participants will receive 1 dose of ABBV-903.

Group Type EXPERIMENTAL

ABBV-903

Intervention Type DRUG

Tablet; oral

Interventions

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ABBV-903

Tablet; oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal, at screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria

* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Acpru /Id# 259438

Grayslake, Illinois, United States

Site Status

Countries

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United States

Related Links

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https://www.abbvieclinicaltrials.com/study/?id=M24-231

Related Info

Other Identifiers

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M24-231

Identifier Type: -

Identifier Source: org_study_id

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