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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT05909553

Run by

AbbVie

People needed

15

Starts

2023-06-15

Expected to finish

2023-09-22

Last updated by the study team

2023-12-01

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Acpru /Id# 255783 — Grayslake, Illinois, United States

Full record on ClinicalTrials.gov

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