Healthy VolunteerPhase 1NCT06742086

A Study to Evaluate the Bioavailability and Food Effects of Oral Venetoclax New Tablet Formulation 2.0 in Healthy Adult Female Participants

A Phase 1 study testing Venetoclax in people with Healthy Volunteer, run by AbbVie at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: Venetoclax
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 2 sitesUnited States
Study dates: 19 Dec 2024to 8 Oct 2025
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Body mass index (BMI) is 18.0 to 32.0 kg/m^2.
Must either be: postmenopausal, permanently surgically sterile, or perimenopausal or premenopausal and practicing a method of birth control until at least 30 days after the last dose of study drug.
Have CD19+ B-cell count > 150 cells/μL at screening.

Who cannot join

History: of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary, or hepatic diseases within the past 6 months that in the option of the investigator would adversely affect her participating in this study.
History of any clinically significant sensitivity or allergy to any medication or food.
History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].

Trial locations and contacts

2 sites in 1 country.

United States2 sites

PPD Phase I Clinic /ID# 275754
Austin, Texas, 78744
Acpru /Id# 272979
Grayslake, Illinois, 60030

Other trials in United States

About this study

Official title: A Bioavailability and Food Effect Study of Venetoclax New Tablet Formulation 2.0 in Healthy Female Subjects

Conditions: Healthy Volunteer
Being tested: Venetoclax
Keywords: Healthy Volunteer, Venetoclax, ABT-199, Venclexta, Venclyxto

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VenetoclaxDrug
Also called ABT-199, Venclexta, Venclyxto
Oral Tablet

Study groups in NCT06742086
Study group	Role	What they receive
Stage 1: Sequence 1: Venetoclax	Experimental	Participants will receive commercial venetoclax following a high-fat meal (Regimen A), followed by venetoclax hot melt extrusion-03 (HME-03) dose A following a high-fat meal (Regimen B), followed by venetoclax HME-03 dose B following a high-fat meal (Regimen C), finally followed by venetoclax HME-03 dose A following fasting (Regimen D), as part of the approximately 18 month study duration. Receives: Drug: Venetoclax
Stage 1: Sequence 2: Venetoclax	Experimental	Participants will receive Regimen B, followed by Regimen C, followed by Regimen A, finally followed by Regimen D, as part of the approximately 18 month study duration. Receives: Drug: Venetoclax
Stage 1: Sequence 3: Venetoclax	Experimental	Participants will receive Regimen C, followed by Regimen A, followed by Regimen B, finally followed by Regimen D, as part of the approximately 18 month study duration. Receives: Drug: Venetoclax
Stage 2: Sequence 1: Venetoclax	Experimental	Participants will receive Regimen A, followed by Regimen B, finally followed by Regimen C, as part of the approximately 18 month study duration. Receives: Drug: Venetoclax
Stage 2: Sequence 2: Venetoclax	Experimental	Participants will receive Regimen B, followed by Regimen C, finally followed by Regimen A, as part of the approximately 18 month study duration. Receives: Drug: Venetoclax
Stage 2: Sequence 3: Venetoclax	Experimental	Participants will receive Regimen C, followed by Regimen A, finally followed by Regimen B, as part of the approximately 18 month study duration. Receives: Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Adverse Events (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately 18 Months
Maximum Observed Plasma Concentration (Cmax) of Venetoclax Hot Melt Extrusion-03 (HME-03)
Cmax of venetoclax HME-03.
Measured: Up to Approximately 18 Months
Time to Cmax (Tmax) of Venetoclax HME-03
Tmax of venetoclax HME-03.
Measured: Up to Approximately 18 Months
Apparent Terminal Phase Elimination Constant (β) of Venetoclax HME-03
β of venetoclax HME-03.
Measured: Up to Approximately 18 Months
Terminal Phase Elimination Half-Life (t1/2) of Venetoclax HME-03
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
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
AUCinf of venetoclax HME-03.
Measured: Up to Approximately 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Dec 20248 Oct 2025

First posted19 Dec 2024
Study start19 Dec 2024
Primary completion8 Oct 2025
Study completion8 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06742086
Sponsor's protocol ID: M25-277
Status last verified: Aug 2025
First submitted: 17 Dec 2024
Last updated: 15 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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