Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

ClinicalTrials.gov ID: NCT06131801

Public ClinicalTrials.gov record NCT06131801. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown. Primary Objectives • To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution Secondary Objectives * To evaluate the safety of crushed venetoclax tablets administered as an oral solution * To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors * To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube) * To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution

Study identification

NCT ID: NCT06131801
Recruitment status: Recruiting
Study type: Observational
Phase: Not listed
Lead sponsor: Children's Hospital Medical Center, Cincinnati; Other
Enrollment: 30 participants

Eligibility (public fields only)

Age range: 0 Years to 38 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 14, 2023
Primary completion: Nov 30, 2026
Completion: Nov 30, 2027
Last update posted: Jun 3, 2026

2023 – 2027

United States locations

U.S. sites: 5
U.S. states: 5
U.S. cities: 5

Facility	City	State	ZIP	Site status
Children's Hospital Colorado	Aurora	Colorado	80045	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Not yet recruiting
Texas Children's Hospital	Houston	Texas	77030	Recruiting
Children's Hospital of Wisconsin	Milwaukee	Wisconsin	53226	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06131801, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 3, 2026 · Synced Sep 18, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06131801 live on ClinicalTrials.gov.

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