← Back to Search

Venetoclax Sequence 1 for Healthy Subjects

Phase 1

Waitlist Available

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 up to 75 days

Awards & highlights

Study Summary

This trial tests how well an oral drug works when crushed or ground, in healthy female participants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 75 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 75 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 75 days 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 the Time Infinity (AUCinf) of Venetoclax

Apparent Terminal Phase Elimination Rate Constant (β) of Venetoclax

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of 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%

White blood cell count decreased

11%

Pneumonia pseudomonal

11%

Hypokalaemia

11%

Dermatitis

11%

Rhinovirus infection

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%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

Trial Design

3Treatment groups

Experimental Treatment

Group I: Venetoclax Sequence 3Experimental Treatment1 Intervention

Participants will receive ground venetoclax, followed by whole venetoclax, and completed with crushed venetoclax for a 15 day period.

Group II: Venetoclax Sequence 2Experimental Treatment1 Intervention

Participants will receive crushed venetoclax, followed by ground venetoclax, and completed with whole venetoclax for a 15 day period.

Group III: Venetoclax Sequence 1Experimental Treatment1 Intervention

Participants will receive whole venetoclax, followed by crushed venetoclax, and completed with ground venetoclax for a 15 day period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

501,090 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,924 Total Patients Enrolled

Frequently Asked Questions

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

Are recruitment efforts for this research study still underway?

"The clinical trial, which was initially published on June 14th 2023 and last updated on the 12th of that same month, is not currently recruiting patients. Nevertheless, 814 other studies are seeking volunteers at this time."

Answered by AI

Who is eligible to participate in this investigation?

"Eligibility criteria for this trial necessitate that potential participants should be of sound health and between 18 to 65 years old. In total, 15 individuals are needed."

Answered by AI

Does this medical trial permit participants aged sixty and above to join?

"The eligibility requirement for this clinical trial is that participants must be between the ages of 18 and 65. In addition, there are 56 trials specifically for those younger than 18 years old and 382 studies geared toward individuals older than 65."

Answered by AI

What are the potential safety risks of using Venetoclax Sequence 1?

"Since this is an early-stage trial, there have been few studies that demonstrate Venetoclax Sequence 1's efficacy and safety. Thus, our team at Power has assigned it a score of 1 on the risk index."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess Adverse Events and Compare How Crushed, Ground, and Intact Oral Tablets Venetoclax Moves Through the Body of Healthy Female Adult Volunteers

2023. "Study to Assess Adverse Events and Compare How Crushed, Ground, and Intact Oral Tablets Venetoclax Moves Through the Body of Healthy Female Adult Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05909553.