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

AbbVie

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Healthy Volunteers

Interventions

VenetoclaxDRUG

Oral; Tablet

Eligibility

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

Medical Language ↔ Plain English

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.

Locations (1)

Acpru /Id# 259897

Grayslake, Illinois, United States

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax) of Venetoclax

Cmax of Venetoclax will be assessed.

Time frame: Up to Day 27

Time to Cmax (Tmax) of Venetoclax

Tmax of Venetoclax will be assessed.

Time frame: 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.

Time frame: Up to Day 27

AUC from Time 0 to Infinity (AUCinf) of Venetoclax

AUCinf of Venetoclax will be assessed.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to Day 57

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.