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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05909553
• Other study ID #: M24-301
• Status: Completed
• Phase: Phase 1
• Start date: June 15, 2023
• Est. completion date: September 22, 2023

Study information

• Verified date: November 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Venetoclax
Oral; Tablet

Locations

Country	Name	City	State
United States	Acpru /Id# 255783	Grayslake	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Adverse Events	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.	Up to 75 Days
Primary	Maximum Observed Plasma Concentration (Cmax) of Venetoclax	Cmax of venetoclax.	Up to 45 Days
Primary	Time to Cmax (Tmax) of Venetoclax	Tmax of venetoclax.	Up to 45 Days
Primary	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Venetoclax	AUCt of venetoclax.	Up to 45 Days
Primary	AUC From Time 0 to the Time Infinity (AUCinf) of Venetoclax	AUCinf of venetoclax.	Up to 45 Days
Primary	Apparent Terminal Phase Elimination Rate Constant (ß) of Venetoclax	Apparent terminal phase elimination rate constant of venetoclax.	Up to 45 Days
Primary	Terminal Phase Elimination Half-life (t1/2) of Venetoclax	T1/2 of venetoclax.	Up to 45 Days

External Links

•   Related Info