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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Dec 2024

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach

1 country

1 active site

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 months study duration

First Submitted

Initial submission to the registry

October 5, 2023

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed

1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed

Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

October 5, 2023

Last Update Submit

September 18, 2024

Conditions

Healthy Volunteers

Keywords

ABBV-903Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

Maximum Observed Plasma Concentration (Cmax) of ABBV-903
Cmax of ABBV-903 will be assessed.
From 0 - 96 hours
Time to Cmax (Tmax) of ABBV-903
Tmax of ABBV-903 will be assessed.
From 0 - 96 hours
Apparent Terminal Phase Elimination Constant (BETA) of ABBV-903
BETA of ABBV-903 will be assessed.
From 0 - 96 hours
Terminal Phase Elimination Half-life (t1/2) of ABBV-903
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
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
AUCt of ABBV-903 will be assessed.
From 0 - 96 hours
AUC from Time 0 to Infinite Time (AUCinf) of ABBV-903
AUCinf of ABBV-903 will be assessed.
From 0 - 96 hours
Number of Participants with Adverse Events
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