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

Sponsor

AbbVie (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06078202

Collaborator

(none)

Enrollment

Arms

2.2

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: ABBV-903	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 5, 2023

Anticipated Primary Completion Date :

Dec 10, 2023

Anticipated Study Completion Date :

Dec 10, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of ABBV-903 [From 0 - 96 hours]
Cmax of ABBV-903 will be assessed.
Time to Cmax (Tmax) of ABBV-903 [From 0 - 96 hours]
Tmax of ABBV-903 will be assessed.
Apparent Terminal Phase Elimination Constant (BETA) of ABBV-903 [From 0 - 96 hours]
BETA of ABBV-903 will be assessed.
Terminal Phase Elimination Half-life (t1/2) of ABBV-903 [From 0 - 96 hours]
Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.
Area Under the Plasma Concentration-time Curve from Time 0 until 24 Hours after Dosing (AUC0-24) of ABBV-903 [From 0 - 96 hours]
AUC0-24 of ABBV-903 will be assessed.
AUC from Time 0 until the Last Measurable Concentration (AUCt) of ABBV-903 [From 0 - 96 hours]
AUCt of ABBV-903 will be assessed.
AUC from Time 0 to Infinite Time (AUCinf) of ABBV-903 [From 0 - 96 hours]
AUCinf of ABBV-903 will be assessed.
Number of Participants with Adverse Events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

AbbVie

ClinicalTrials.gov Identifier:

NCT06078202

Other Study ID Numbers:

M24-231

First Posted:

Oct 11, 2023

Last Update Posted:

Oct 11, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by AbbVie

ABBV-903

Healthy Volunteers

Study Results

No Results Posted as of Oct 11, 2023