Venetoclax for Healthy Subjects

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: AbbVie

Disqualifiers: Renal, Neurologic, Psychiatric, others

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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. Additionally, this study will assess the potential food effect on the BA of the venetoclax HME-03 tablet at the highest dosage strength.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug Venetoclax unique compared to other treatments?

Venetoclax is unique because it specifically targets and inhibits a protein called BCL-2, which helps cancer cells survive, making it different from other treatments that may not target this protein directly. ^{1 2 3 4 5}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for healthy adult women. Participants must not have any significant health issues, be non-smokers or willing to abstain from smoking, and cannot be pregnant. They should not have taken any other medications recently that could affect the study results.

Inclusion Criteria

Body mass index (BMI) is 18.0 to 32.0 kg/m^2

I am either postmenopausal, surgically sterile, or using birth control if premenopausal.

Have CD19+ B-cell count > 150 cells/μL at screening

Exclusion Criteria

History of any clinically significant sensitivity or allergy to any medication or food

I have a condition or had surgery that could affect my stomach or intestine's function.

History of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary, or hepatic diseases within the past 6 months that in the opinion of the investigator would adversely affect participation in this study

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive various regimens of venetoclax under high-fat and fasting conditions to assess bioavailability and food effects

Approximately 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Venetoclax (BCL-2 Inhibitor)

Trial Overview The study tests a new tablet form of Venetoclax, a medication typically used in certain blood cancers. It compares how the body absorbs this new version with food versus the standard one without food in healthy female volunteers.

Participant Groups

Group I: Stage 2: Sequence 3: Venetoclax Experimental Treatment 1 Intervention

Participants will receive Regimen C, followed by Regimen A, finally followed by Regimen B, as part of the approximately 18 month study duration.

Group II: Stage 2: Sequence 2: Venetoclax Experimental Treatment 1 Intervention

Participants will receive Regimen B, followed by Regimen C, finally followed by Regimen A, as part of the approximately 18 month study duration.

Group III: Stage 2: Sequence 1: Venetoclax Experimental Treatment 1 Intervention

Participants will receive Regimen A, followed by Regimen B, finally followed by Regimen C, as part of the approximately 18 month study duration.

Group IV: Stage 1: Sequence 3: Venetoclax Experimental Treatment 1 Intervention

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.

Group V: Stage 1: Sequence 2: Venetoclax Experimental Treatment 1 Intervention

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.

Group VI: Stage 1: Sequence 1: Venetoclax Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

In a 4-week trial involving 18 patients with retinal vein thrombosis, pentoxifylline (PXF) at 1600 mg daily significantly improved retinal flow compared to placebo, with a 350% increase in retinal vein flow velocity (RVFV) versus 200% in the placebo group.

No side effects were reported, and PXF also led to a greater reduction in visual analogue scores, indicating better clinical outcomes, making it a promising treatment option for retinal vein thrombosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of retinal vein thrombosis with pentoxifylline: a controlled, randomized trial. De Sanctis, MT., Cesarone, MR., Belcaro, G., et al.[2013]

In a study of 485 claudicant patients, those with a maximal walking distance of 250 meters or less showed significant improvement in walking capacity when treated with propionyl-L-carnitine compared to placebo, with a 98% increase in walking distance for the treatment group.

Patients with mild functional impairment (walking distance greater than 250 meters) did not benefit from propionyl-L-carnitine, indicating that the treatment is most effective for those with more severe walking limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European multicenter study on propionyl-L-carnitine in intermittent claudication. Brevetti, G., Diehm, C., Lambert, D.[2019]

The H-1337 ophthalmic solution demonstrated significant reductions in intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension, with mean changes of -4.45, -5.16, and -4.93 mmHg for the different concentrations compared to a vehicle control, indicating its efficacy as a treatment.

While 49% of subjects experienced treatment-emergent adverse events, most were mild, suggesting that H-1337 is generally well tolerated, with only a small number of moderate intensity side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase Ⅰ/Ⅱ, Double-Masked, Randomized, Vehicle-Controlled Study of H-1337 Ophthalmic Solution for Glaucoma and Ocular Hypertension. Hartman, PJ., Cooke, DL., Hsu, HH., et al.[2023]

In a randomized double-blind study of 42 patients with primary open-angle glaucoma (POAG), Naftidrofuryl did not show significant efficacy compared to placebo across most measured parameters, including intraocular pressure and visual acuity.

The only notable finding was a decrease in CLV (a specific measure) at 12 weeks in the Naftidrofuryl group, suggesting that while it may have some effect, it is not as effective for POAG as it is for normal tension glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of naftidrofuryl (Praxilene) in primary open angle glaucoma: prospective double-blind study]. Beati, D., Mermoud, A., Faggioni, R.[2013]

In a meta-analysis of 28 studies involving 386 patients, bimatoprost and travoprost were found to be the most effective ocular hypotensive medications, achieving a 29% and 27% reduction in intraocular pressure (IOP) over 24 hours, respectively.

The study also revealed that evening dosing of latanoprost resulted in a greater IOP reduction (24%) compared to morning dosing (18%), highlighting the importance of dosing time in managing glaucoma effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of 24-hour intraocular pressure studies evaluating the efficacy of glaucoma medicines. Stewart, WC., Konstas, AG., Nelson, LA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of retinal vein thrombosis with pentoxifylline: a controlled, randomized trial. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

European multicenter study on propionyl-L-carnitine in intermittent claudication. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Phase Ⅰ/Ⅱ, Double-Masked, Randomized, Vehicle-Controlled Study of H-1337 Ophthalmic Solution for Glaucoma and Ocular Hypertension. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

[Effect of naftidrofuryl (Praxilene) in primary open angle glaucoma: prospective double-blind study]. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of 24-hour intraocular pressure studies evaluating the efficacy of glaucoma medicines. [2022]