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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-05

Study Completion Date

2025-07-28

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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Regimen A

Participants will receive venetoclax dose A commercial formulation following a high-fat meal.

Group Type EXPERIMENTAL

Venetoclax

Intervention Type DRUG

Oral; Tablet

Regimen B

Participants will receive venetoclax dose B new formulation following a high-fat meal.

Group Type EXPERIMENTAL

Venetoclax

Intervention Type DRUG

Oral; Tablet

Regimen C

Participants will receive venetoclax dose A new formulation following a high-fat meal.

Group Type EXPERIMENTAL

Venetoclax

Intervention Type DRUG

Oral; Tablet

Regimen D

Participants will receive venetoclax dose B new formulation under fasted conditions.

Group Type EXPERIMENTAL

Venetoclax

Intervention Type DRUG

Oral; Tablet

Interventions

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Venetoclax

Oral; Tablet

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes