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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05836506

Enrollment

Registered

2023-05-01

Start date

2023-04-18

Completion date

2023-06-20

Last updated

2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

ABBV-903, Healthy Volunteer

Brief summary

The main objective of this study is to assess the relative bioavailability and pharmacokinetics of ABBV-903 in healthy adult participants.

Interventions

DRUGABBV-903 Tablet Form 1

Oral Tablets

DRUGABBV-903 Tablet Form 2

Oral Tablets

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth. * Negative test result for SARS-CoV-2 infection at screening visit 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 ECG.

Exclusion criteria

* 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. * History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Adverse Events (AEs)	Up to Approximately 44 days	An 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
Maximum Plasma Concentration (Cmax) of ABBV-903	Up to approximately 14 days	Cmax of ABBV-903
Time to Cmax (Tmax) of ABBV-903	Up to approximately 14 days	Tmax of ABBV-903
Terminal Phase Elimination Half-Life (t1/2) of ABBV-903	Up to approximately 14 days	Terminal phase elimination half-life of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903	Up to approximately 14 days	AUCt of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903	Up to approximately 14 days	AUCinf of ABBV-903

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026