Trials / Completed
CompletedNCT06742086
A Study to Evaluate the Bioavailability and Food Effects of Oral Venetoclax New Tablet Formulation 2.0 in Healthy Adult Female Participants
A Bioavailability and Food Effect Study of Venetoclax New Tablet Formulation 2.0 in Healthy Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Venetoclax | Oral Tablet |
Timeline
- Start date
- 2024-12-19
- Primary completion
- 2025-10-08
- Completion
- 2025-10-08
- First posted
- 2024-12-19
- Last updated
- 2025-10-15
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06742086. Inclusion in this directory is not an endorsement.