Study to Assess Adverse Events and Compare How Crushed, Ground, and Intact Oral Tablets Venetoclax Moves Through the Body of Healthy Female Adult Volunteers

Study Overview
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Brief Summary
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The objective of this study is to assess the oral bioavailability of crushed and ground venetoclax commercial tablets relative to the intact venetoclax commercial tablets under fed condition in healthy female participants.

Official Title
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A Phase 1, Open-Label Study to Evaluate the Effect of Crushing and Grinding on the Bioavailability of Venetoclax Tablet in Healthy Adult 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: Must either 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. 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: Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease within the past 6 months that in the opinion of the investigator would adversely affect her participating in this study. History of any clinically significant sensitivity or allergy to any medication or food. History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venetoclax Sequence 1<br>Participants will receive whole venetoclax, followed by crushed venetoclax, and completed with ground venetoclax for a 15 day period. | Drug: Venetoclax<br>* Oral; Tablet<br>* Other names: Venclaxta;|
| Experimental: Venetoclax Sequence 2<br>Participants will receive crushed venetoclax, followed by ground venetoclax, and completed with whole venetoclax for a 15 day period. | Drug: Venetoclax<br>* Oral; Tablet<br>* Other names: Venclaxta;|
| Experimental: Venetoclax Sequence 3<br>Participants will receive ground venetoclax, followed by whole venetoclax, and completed with crushed venetoclax for a 15 day period. | Drug: Venetoclax<br>* Oral; Tablet<br>* Other names: Venclaxta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Adverse Events | An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to 75 Days | 
| Maximum Observed Plasma Concentration (Cmax) of Venetoclax | Cmax of venetoclax. | Up to 45 Days | 
| Time to Cmax (Tmax) of Venetoclax | Tmax of venetoclax. | Up to 45 Days | 
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Venetoclax | AUCt of venetoclax. | Up to 45 Days | 
| AUC From Time 0 to the Time Infinity (AUCinf) of Venetoclax | AUCinf of venetoclax. | Up to 45 Days | 
| Apparent Terminal Phase Elimination Rate Constant (β) of Venetoclax | Apparent terminal phase elimination rate constant of venetoclax. | Up to 45 Days | 
| Terminal Phase Elimination Half-life (t1/2) of Venetoclax | T1/2 of venetoclax. | Up to 45 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, Venetoclax, ABT-199