A Study to Assess Food Effect of Venetoclax New Tablet Formulation in Healthy Female Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess the bioavailability of two different doses of venetoclax new high drug load formulation tablets relative to two tablets of the currently marketed venetoclax tablets under fed conditions.

Official Title
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A Bioavailability and Food Effect Study of Venetoclax New High Drug Load Tablet Formulation in Healthy Female Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Venetoclax


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. 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). Participant must be postmenopausal, permanently surgically sterile, or perimenopausal or premenopausal and practicing a method of birth control until at least 1 month after the last dose of study drug. 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.

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

Sexes Eligible for Study
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Female

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: Regimen A<br>Participants will receive venetoclax dose A commercial formulation following a high-fat meal. | Drug: Venetoclax<br>* Oral; Tablet<br>|
| Experimental: Regimen B<br>Participants will receive venetoclax dose B new formulation following a high-fat meal. | Drug: Venetoclax<br>* Oral; Tablet<br>|
| Experimental: Regimen C<br>Participants will receive venetoclax dose A new formulation following a high-fat meal. | Drug: Venetoclax<br>* Oral; Tablet<br>|
| Experimental: Regimen D<br>Participants will receive venetoclax dose B new formulation under fasted conditions. | Drug: Venetoclax<br>* Oral; Tablet<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 Venetoclax | Cmax of Venetoclax will be assessed. | Up to Day 27 | 
| Time to Cmax (Tmax) of Venetoclax | Tmax of Venetoclax will be assessed. | Up to Day 27 | 
| Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUCt) of Venetoclax | AUCt of Venetoclax will be assessed. | Up to Day 27 | 
| AUC from Time 0 to Infinity (AUCinf) of Venetoclax | AUCinf of Venetoclax will be assessed. | Up to Day 27 | 
| Apparent Terminal Phase Elimination Rate Constant (β, BETA) of Venetoclax | Apparent terminal phase elimination rate constant (β, BETA) of Venetoclax will be assessed. | Up to Day 27 | 
| Terminal Phase Elimination Half-life (t1/2) of Venetoclax | Terminal phase elimination half-life (t1/2) of Venetoclax will be assessed. | Up to Day 27 | 
| Number of Adverse Events (AEs) | 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. | Baseline to Day 57 | 

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