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Food Effect on Venetoclax Absorption in Healthy Women

Phase 1
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 57
Awards & highlights

Study Summary

This trial tests how well two different doses of a new drug work in the body compared to the current version.

Who is the study for?
This trial is for healthy women who are postmenopausal, surgically sterile, or using birth control. They must have a BMI between 18.0 and 32.0 kg/m2 and be in good health as determined by medical exams, lab tests, and ECGs. Women with recent illnesses, infections requiring hospitalization, or surgery within the last 30 days cannot participate.Check my eligibility
What is being tested?
The study is testing how two different doses of a new tablet form of Venetoclax are absorbed by the body when taken with food compared to the current version of the tablets.See study design
What are the potential side effects?
While this trial involves healthy participants and focuses on drug absorption rather than treatment effects, potential side effects of Venetoclax can include nausea, diarrhea, low white blood cell counts (neutropenia), upper respiratory tract infection, fatigue, and cough.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 57
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC from Time 0 to Infinity (AUCinf) of Venetoclax
Apparent Terminal Phase Elimination Rate Constant (β, BETA) of Venetoclax
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUCt) of Venetoclax
+4 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Trial Design

4Treatment groups
Experimental Treatment
Group I: Regimen DExperimental Treatment1 Intervention
Participants will receive venetoclax dose B new formulation under fasted conditions.
Group II: Regimen CExperimental Treatment1 Intervention
Participants will receive venetoclax dose A new formulation following a high-fat meal.
Group III: Regimen BExperimental Treatment1 Intervention
Participants will receive venetoclax dose B new formulation following a high-fat meal.
Group IV: Regimen AExperimental Treatment1 Intervention
Participants will receive venetoclax dose A commercial formulation following a high-fat meal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,312 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,026 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criterion for this trial extend to individuals over thirty years of age?

"This clinical trial is restricted to persons aged 18-65. Separately, there are 64 studies for minors and 396 trials targeting individuals 65 years or older."

Answered by AI

What potential risks should be considered before using Regimen A?

"The safety profile for Regimen A was evaluated as a 1 since it is in the initial phase of testing and there is limited data to support its efficacy or security."

Answered by AI

Do I meet the criteria for participating in this clinical research?

"To be admitted to this medical trial, participants must meet the criteria of a healthy volunteer and have an age between 18 and 65. The approved number of patients is 72."

Answered by AI

Are there any vacancies for participants in this research effort?

"According to clinicaltrials.gov, the current recruitment status of this medical trial is open; it was first posted on October 2nd 2023 and saw its latest update take place on that same day."

Answered by AI

How many individuals are actively involved in this research trial?

"Affirmative. According to the information that is hosted on clinicaltrials.gov, this medical trial remains open for enrolment and actively searching for participants. This study was first posted in October 2nd 2023 and recently updated as of the same date with a goal of recruiting 72 patients at one location."

Answered by AI

Who else is applying?

What site did they apply to?
Acpru /Id# 259897
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Food Effect of Venetoclax New Tablet Formulation in Healthy Female Participants
2023. "A Study to Assess Food Effect of Venetoclax New Tablet Formulation in Healthy Female Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06070948.
All > Madison
~48 spots leftby Apr 2025
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