A Study to Evaluate the Bioavailability and Food Effects of Oral Venetoclax New Tablet Formulation 2.0 in Healthy Adult Female Participants
Study Identifier
M25-277
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete
Study Details
Medical Condition
Study Drug
Phase
Phase 1
Sex
Female
Age
18 - 65 Years
Protocol Summary
The objective of this study is to assess the bioavailability (BA) of venetoclax new high drug load hot melt extrusion-03 (HME-03) tablet formulation at two different tablet strengths relative to the commercial venetoclax tablet formulation under high-fat conditions in healthy female volunteers. Additionally, this study will assess the potential food effect on the BA of the venetoclax HME-03 tablet at the highest dosage strength.
Study Locations
Location
Status
Location
Acpru /Id# 272979
Grayslake, Illinois, United States, 60030
Status
Not applicable
Location
PPD Phase I Clinic /ID# 275754
Austin, Texas, United States, 78744
Status
Not applicable