A Study to Evaluate the Bioavailability and Food Effects of Oral Venetoclax New Tablet Formulation 2.0 in Healthy Adult Female Participants
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
72actual
Sites
2
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-12-19 | actual | When the study began enrolling |
| Primary completion | 2025-10-08 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-08 | actual | The whole study's end, after follow-up |
| First posted | 2024-12-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteer
Intervention
- Drug: Venetoclax — also filed as ABT-199, Venclexta, Venclyxto
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Adverse Events (AE)
measured Up to Approximately 18 Months
Maximum Observed Plasma Concentration (Cmax) of Venetoclax Hot Melt Extrusion-03 (HME-03)
measured Up to Approximately 18 Months
Time to Cmax (Tmax) of Venetoclax HME-03
measured Up to Approximately 18 Months
Apparent Terminal Phase Elimination Constant (β) of Venetoclax HME-03
measured Up to Approximately 18 Months
Terminal Phase Elimination Half-Life (t1/2) of Venetoclax HME-03
measured Up to Approximately 18 Months
Area Under the Plasma Concentration-Time Curve from Time 0 Until the Last Measurable Concentration (AUCt) of Venetoclax HME-03
measured Up to Approximately 18 Months
Area Under the Plasma Concentration-Time Curve from Time 0 Until Infinity (AUCinf) of Venetoclax HME-03
measured Up to Approximately 18 Months
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