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 15 enrolled AbbVie

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2023-06-15
Primary completion: 2023-09-22
Completion: 2023-09-22

Publications

Alaei S, Wang Y, Liu Y, Schiele J, Deng R, Shiller D, Marroum P, Menon R, Salem AH. Venetoclax Clinical Pharmacokinetics After Administration of Crushed, Ground or Whole Tablets. Clin Ther. 2024 Oct;46(10):752-758. doi: 10.1016/j.clinthera.2024.03.012. Epub 2024 May 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Venetoclax	Small molecule	—	Oral

Indications

No indication recorded.