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

October 5, 2023 updated by: AbbVie

Assessment of the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Volunteers

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1, Sequence A
Participants will receive 1 dose of ABBV-903.
Drug: ABBV-903
Tablet; oral
Experimental: Part 1, Sequence B
Participants will receive 1 dose of ABBV-903.
Drug: ABBV-903
Tablet; oral
Experimental: Part 1, Sequence C
Participants will receive 1 dose of ABBV-903.
Drug: ABBV-903
Tablet; oral
Experimental: Part 2, Sequence A
Participants will receive 1 dose of ABBV-903.
Drug: ABBV-903
Tablet; oral
Experimental: Part 2, Sequence B
Participants will receive 1 dose of ABBV-903.
Drug: ABBV-903
Tablet; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of ABBV-903
Time Frame: From 0 - 96 hours
Cmax of ABBV-903 will be assessed.
From 0 - 96 hours
Time to Cmax (Tmax) of ABBV-903
Time Frame: From 0 - 96 hours
Tmax of ABBV-903 will be assessed.
From 0 - 96 hours
Apparent Terminal Phase Elimination Constant (BETA) of ABBV-903
Time Frame: From 0 - 96 hours
BETA of ABBV-903 will be assessed.
From 0 - 96 hours
Terminal Phase Elimination Half-life (t1/2) of ABBV-903
Time Frame: From 0 - 96 hours
Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.
From 0 - 96 hours
Area Under the Plasma Concentration-time Curve from Time 0 until 24 Hours after Dosing (AUC0-24) of ABBV-903
Time Frame: From 0 - 96 hours
AUC0-24 of ABBV-903 will be assessed.
From 0 - 96 hours
AUC from Time 0 until the Last Measurable Concentration (AUCt) of ABBV-903
Time Frame: From 0 - 96 hours
AUCt of ABBV-903 will be assessed.
From 0 - 96 hours
AUC from Time 0 to Infinite Time (AUCinf) of ABBV-903
Time Frame: From 0 - 96 hours
AUCinf of ABBV-903 will be assessed.
From 0 - 96 hours
Number of Participants with Adverse Events
Time Frame: Up to 42 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to 42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 5, 2023

Primary Completion (Estimated)

December 10, 2023

Study Completion (Estimated)

December 10, 2023

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M24-231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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