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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Venetoclax

• Registration Number: NCT05909553
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-12
• Study Start: 2023-06-15
• Study First Posted: 2023-06-18
• Primary Completion: 2023-09-22
• Study Completion: 2023-09-22
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venetoclax Sequence 2	Venetoclax	Participants will receive crushed venetoclax, followed by ground venetoclax, and completed with whole venetoclax for a 15 day period.
Venetoclax Sequence 1	Venetoclax	Participants will receive whole venetoclax, followed by crushed venetoclax, and completed with ground venetoclax for a 15 day period.
Venetoclax Sequence 3	Venetoclax	Participants will receive ground venetoclax, followed by whole venetoclax, and completed with crushed venetoclax for a 15 day period.

Primary Outcome Measures

Name	Time	Method
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.
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.
Apparent Terminal Phase Elimination Rate Constant (β) of Venetoclax	Up to 45 Days	Apparent terminal phase elimination rate constant of venetoclax.
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.
AUC From Time 0 to the Time Infinity (AUCinf) of Venetoclax	Up to 45 Days	AUCinf of venetoclax.
Terminal Phase Elimination Half-life (t1/2) of Venetoclax	Up to 45 Days	T1/2 of venetoclax.

Trial Locations

Locations (1)

Acpru /Id# 255783; 🇺🇸 Grayslake, Illinois, United States