Study to Assess Adverse Events and Compare How Crushed, Ground, and Intact Oral Tablets Venetoclax Moves Through the Body of Healthy Female Adult Volunteers

A Phase 1, Open-Label Study to Evaluate the Effect of Crushing and Grinding on the Bioavailability of Venetoclax Tablet in Healthy Adult Female Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05909553

Enrollment

Registered

2023-06-18

Start date

2023-06-15

Completion date

2023-09-22

Last updated

2023-12-01

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

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers, Venetoclax, ABT-199

Brief summary

The objective of this study is to assess the oral bioavailability of crushed and ground venetoclax commercial tablets relative to the intact venetoclax commercial tablets under fed condition in healthy female participants.

Interventions

DRUGVenetoclax

Oral; Tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Must either 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. * 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).

Exclusion criteria

* Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease within the past 6 months that in the opinion of the investigator would adversely affect her participating in this study. * History of any clinically significant sensitivity or allergy to any medication or food. * History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Experiencing Adverse Events	Up to 75 Days	An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Maximum Observed Plasma Concentration (Cmax) of Venetoclax	Up to 45 Days	Cmax of venetoclax.
Time to Cmax (Tmax) of Venetoclax	Up to 45 Days	Tmax of venetoclax.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Venetoclax	Up to 45 Days	AUCt of venetoclax.
AUC From Time 0 to the Time Infinity (AUCinf) of Venetoclax	Up to 45 Days	AUCinf of venetoclax.
Apparent Terminal Phase Elimination Rate Constant (β) of Venetoclax	Up to 45 Days	Apparent terminal phase elimination rate constant of venetoclax.
Terminal Phase Elimination Half-life (t1/2) of Venetoclax	Up to 45 Days	T1/2 of venetoclax.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026