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

Study Overview
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ABBV-903


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABBV-903, Healthy Volunteers