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

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

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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: ABBV-903 Tablet Form 1
* Drug: ABBV-903 Tablet Form 2


Participation Criteria
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Eligibility Criteria
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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.

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>In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after a high fat meal. Participants will be followed up for 30 days. | Drug: ABBV-903 Tablet Form 1<br>* Oral Tablets<br>Drug: ABBV-903 Tablet Form 2<br>* Oral Tablets<br>|
| Experimental: Part 1: Sequence B<br>In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Participants will be followed up for 30 days. | Drug: ABBV-903 Tablet Form 1<br>* Oral Tablets<br>Drug: ABBV-903 Tablet Form 2<br>* Oral Tablets<br>|
| Experimental: Part 2: Sequence A<br>In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after a high fat meal. Participants will be followed up for 30 days. | Drug: ABBV-903 Tablet Form 1<br>* Oral Tablets<br>Drug: ABBV-903 Tablet Form 2<br>* Oral Tablets<br>|
| Experimental: Part 2: Sequence B<br>In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Participants will be followed up for 30 days. | Drug: ABBV-903 Tablet Form 1<br>* Oral Tablets<br>Drug: ABBV-903 Tablet Form 2<br>* Oral Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

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

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