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

AbbVie

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Venetoclax

Study type: Interventional

Funder types: Industry

Identifiers

NCT06070948

M22-457

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

0 participants in 4 patient groups

Regimen A

Experimental group

Description:

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

Treatment:

Drug: Venetoclax

Regimen B

Experimental group

Description:

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

Treatment:

Drug: Venetoclax

Regimen C

Experimental group

Description:

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

Treatment:

Drug: Venetoclax

Regimen D

Experimental group

Description:

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

Treatment:

Drug: Venetoclax