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

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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Withdrawn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

Trial contacts and locations

1

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Central trial contact

ABBVIE CALL CENTER

Data sourced from clinicaltrials.gov

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