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

A Bioavailability and Food Effect Study of Venetoclax New High Drug Load Tablet Formulation in Healthy Female Subjects

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06070948

Enrollment

Registered

2023-10-06

Start date

2023-10-05

Completion date

2025-07-28

Last updated

2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Venetoclax

Brief summary

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.

Interventions

DRUGVenetoclax

Oral; Tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Maximum Observed Plasma Concentration (Cmax) of Venetoclax	Up to Day 27	Cmax of Venetoclax will be assessed.
Time to Cmax (Tmax) of Venetoclax	Up to Day 27	Tmax of Venetoclax will be assessed.
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUCt) of Venetoclax	Up to Day 27	AUCt of Venetoclax will be assessed.
AUC from Time 0 to Infinity (AUCinf) of Venetoclax	Up to Day 27	AUCinf of Venetoclax will be assessed.
Apparent Terminal Phase Elimination Rate Constant (β, BETA) of Venetoclax	Up to Day 27	Apparent terminal phase elimination rate constant (β, BETA) of Venetoclax will be assessed.
Terminal Phase Elimination Half-life (t1/2) of Venetoclax	Up to Day 27	Terminal phase elimination half-life (t1/2) of Venetoclax will be assessed.
Number of Adverse Events (AEs)	Baseline to Day 57	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026