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

AbbVie15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

VenetoclaxDRUG

Oral; Tablet

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Acpru /Id# 255783

Grayslake, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 75 Days

Maximum Observed Plasma Concentration (Cmax) of Venetoclax

Cmax of venetoclax.

Time frame: Up to 45 Days

Time to Cmax (Tmax) of Venetoclax

Tmax of venetoclax.

Time frame: 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.

Time frame: Up to 45 Days

AUC From Time 0 to the Time Infinity (AUCinf) of Venetoclax

AUCinf of venetoclax.

Time frame: Up to 45 Days

Apparent Terminal Phase Elimination Rate Constant (β) of Venetoclax

Apparent terminal phase elimination rate constant of venetoclax.

Time frame: Up to 45 Days

Terminal Phase Elimination Half-life (t1/2) of Venetoclax

T1/2 of venetoclax.

Time frame: Up to 45 Days

Data from ClinicalTrials.gov

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