Tavapadon Bioavailability Study

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Epilepsy, Cardiac, Respiratory, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 22 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the body absorbs two different formulations of the drug tavapadon. Researchers are testing tavapadon to determine how effectively it enters the bloodstream when taken orally by healthy adults. The study includes four groups, each receiving different sequences of tavapadon dosages. Individuals who are generally healthy and do not have significant medical issues, aside from mild childhood asthma, may be suitable candidates for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, providing participants the opportunity to be among the first to receive this new drug.

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 study team or your doctor.

Is there any evidence suggesting that tavapadon is likely to be safe for humans?

Research has shown that tavapadon has been tested in several studies and is considered safe for treating Parkinson's disease. Many studies have found it to be well-tolerated by patients. For instance, one study reported no unexpected safety issues, with patients' vital signs and lab results remaining normal. Another study found that patients taking tavapadon did not experience troublesome side effects compared to those taking a placebo. An ongoing study examining the long-term safety of tavapadon over 58 weeks suggests confidence in its safety.

This trial focuses on healthy adults and is in an early phase, primarily to understand how the body absorbs different forms of the drug. While this study differs slightly, the safety data from previous studies in Parkinson's patients provides reassurance. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Tavapadon is unique because it targets dopamine D1/D5 receptors in the brain, which is different from the typical dopamine replacement therapies or agonists currently used for Parkinson's disease. This novel mechanism of action aims to provide a more precise modulation of dopamine pathways, potentially leading to improved motor control and fewer side effects. Researchers are excited about Tavapadon as it offers a promising alternative that could enhance quality of life for patients by addressing both motor and non-motor symptoms more effectively than existing treatments.

What evidence suggests that this trial's treatments could be effective?

Research has shown that tavapadon may help treat Parkinson's disease. In earlier studies, patients who took tavapadon had better control over their movements compared to those who took a placebo, a pill with no active medicine. Tavapadon affects dopamine receptors, which are important for movement and coordination, helping to improve symptoms in people with Parkinson’s. Additionally, studies have shown tavapadon to be safe, making it a promising option for early treatment. Overall, the current evidence supports its potential to help manage Parkinson's symptoms.

In this trial, participants will receive different sequences of tavapadon doses to study its bioavailability. ^{2 5 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for healthy adults who are either permanently sterile or postmenopausal women under 55 with no menses for a year and an FSH level ≥ 30 IU/L. Participants must be in good health as determined by medical exams, have a BMI between 18.0 to ≤ 32.0 kg/m2, and cannot be pregnant or breastfeeding.

Inclusion Criteria

Body Mass Index (BMI) must be ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening

My overall health is good based on recent medical exams.

I am a woman who cannot have children due to surgery, certain conditions, or being postmenopausal.

Exclusion Criteria

Use of tobacco- or nicotine-containing products within 90 days prior to the first dose of study treatment.

History of suicidal ideation within one year prior to study drug administration as evidenced by answering 'yes' to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity rating scale (C-SSRS) completed at Screening, or any history of suicide attempts within the last two years

I do not have any significant ongoing health issues like heart, lung (except mild childhood asthma), kidney, liver, stomach, blood, or mental health problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different oral formulations of Tavapadon in multiple sequences and periods

22 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

31 days

What Are the Treatments Tested in This Trial?

Interventions

• Tavapadon

Trial Overview The study is testing the bioavailability (how well the body absorbs) of two different oral formulations of tavapadon—a drug—in healthy adults to see which one works better.

How Is the Trial Designed?

Group I: Tavapadon: Part 2-Sequence 2 Experimental Treatment 1 Intervention

Participants will receive Clinical Tavapadon Dose C in Period 1, Commercial Tavapadon Dose E in Period 2 followed by Clinical Tavapadon Dose D in Period 3

Group II: Tavapadon: Part 2-Sequence 1 Experimental Treatment 1 Intervention

Participants will receive Clinical Tavapadon Dose C in Period 1, Clinical Tavapadon Dose D in Period 2 followed by Commercial Tavapadon Dose E in Period 3

Group III: Tavapadon: Part 1-Sequence 2 Experimental Treatment 1 Intervention

Participants will receive Commercial Clinical Tavapadon Dose B in Period 1, followed by Clinical Tavapadon Dose A in Period 2

Group IV: Tavapadon: Part 1-Sequence 1 Experimental Treatment 1 Intervention

Participants will receive Clinical Tavapadon Dose A in Period 1, followed by Commercial Tavapadon Dose B in Period 2

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468602/

Emerging Clinical Role of Tavapadon, a Novel Dopamine ... Recent late-stage results have revealed that Tavapadon maintains superior UPDRS outcomes in de novo patients and, when added to levodopa ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06895356?term=AREA%5BInterventionSearch%5D(TAVAPADON)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=1

A Study to Assess the Relative Bioavailability of Oral ... This study will assess the relative bioavailability of two different Oral formulations of tavapadon in healthy adult participants. Official Title. A Phase 1, ...

3. neurology.org neurology.org/doi/10.1212/WNL.98.18_supplement.2728

Summary of Phase 1 Clinical Studies (P10-11.001) Due to low recovery of tavapadon in urine (<2%) and its extensive hepatic metabolism, planned studies will evaluate PK and safety in patients ...

4. michaeljfox.org michaeljfox.org/news/new-parkinsons-drug-tavapadon-submitted-fda-review

New Parkinson's Drug Tavapadon Submitted for FDA Review Results showed that compared with the placebo group, volunteers who received tavapadon experienced a significant improvement in motor symptoms ...

5. drughunter.com drughunter.com/molecule/tavapadon-cvl-751-pf-06649751

tavapadon (CVL-751, PF-06649751) Tavapadon's safety and efficacy profile offers the potential for it to be utilized in the early stages of the disease, thus providing a near- ...

6. neurology.org neurology.org/doi/10.1212/WNL.0000000000208468

Efficacy and Safety of Tavapadon, an Orally Administered ... Treatment with tavapadon (5–15 mg once daily) significantly increased total daily ON time without troublesome dyskinesia by 1.1 hours relative to placebo.

7. news.abbvie.com news.abbvie.com/2025-09-26-AbbVie-Submits-New-Drug-Application-to-U-S-FDA-for-Tavapadon-for-the-Treatment-of-Parkinsons-Disease

AbbVie Submits New Drug Application to U.S. FDA for ... An open-label extension study (TEMPO-4) is ongoing to assess the long-term safety and efficacy of tavapadon through 58 weeks of treatment.

8. neurologylive.com neurologylive.com/view/parkinson-agent-tavapadon-continued-efficacy-safety-phase-3-tempo-4-trial

Parkinson Agent Tavapadon Shows Continued Efficacy ... Overall, tavapadon was considered safety, with no new safety signals identified, including vital signs or laboratory/electrocardiogram findings.