A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers

Study Overview
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Brief Summary
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The primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of AB521 tablet versus the AB521 capsule, and to evaluate the effect of food on the single-dose PK of AB521 tablet in healthy adult volunteers.

Official Title
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A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Way Crossover, Pharmacokinetic Study to Evaluate the Relative Bioavailability of AB521 Tablet and Capsule Formulations and the Effect of Food on the Pharmacokinetics of the Tablet Formulation in Healthy Adult Volunteers

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: AB521


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on volunteer self-reporting Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilogram (kg)/square meter (m^2) at the screening visit, with body weight ≥ 45 kg Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the study physician Able to swallow multiple capsules and tablets Has adequate peripheral venous access Key Exclusion Criteria: Has active neoplastic disease or history of neoplastic disease within 5 years of the screening visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care) Has abnormal liver enzyme test results or hematology values at the time of enrollment Has a history of additional risk factors for Torsades de pointes (example: heart failure, hypokalemia, family history of Long QT Syndrome) Malabsorption condition that would alter the absorption of orally administered medications at the discretion of the study physician Participation in another clinical study within 90 days or within 5 half-lives (if known), prior to the first dosing, whichever is longer. The 90-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AB521 - Sequence ABC<br>Participants will sequentially receive AB521 capsules fasted (Treatment A), followed by AB521 tablets fasted (Treatment B), followed by AB521 tablets fed (Treatment C) | Drug: AB521<br>* Administered as specified in the treatment arm<br>|
| Experimental: AB521 - Sequence BCA<br>Participants will sequentially receive Treatment B, followed by Treatment C, then Treatment A | Drug: AB521<br>* Administered as specified in the treatment arm<br>|
| Experimental: AB521 - Sequence CAB<br>Participants will sequentially receive Treatment C, followed by Treatment A, then Treatment B | Drug: AB521<br>* Administered as specified in the treatment arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Drug Concentration-Time Curve (AUC) |  | Predose, Up to 168 hours postdose | 
| Maximum Concentration (Cmax) |  | Predose, Up to 168 hours postdose | 
| Time to Maximum Concentration (Tmax) |  | Predose, Up to 168 hours postdose | 
| Terminal Half-Life Time (t1/2) |  | Predose, Up to 168 hours postdose | 
| Apparent Total Plasma Clearance (CL/F) |  | Predose, Up to 168 hours postdose | 
| Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) |  | Predose, Up to 168 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events |  | Up to 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AB521