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Parkinson DiseasePhase 1NCT05610189

Multiple-dose Trial to Determine the Clinical Bioequivalence Between Tavapadon Tablets in Participants With Parkinson's Disease

A Phase 1 study testing Tavapadon in people with Parkinson Disease, run by Cerevel Therapeutics, LLC at 6 sites in United States.

Completed

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

Official record
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Trial summary

The primary purpose of the study is to evaluate the bioequivalence (BE) of tavapadon 15 milligram (mg) tablet to 3x5 mg tablets in participants with Parkinson's disease. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Tavapadon
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
6 sitesUnited States
Study dates
15 Dec 2022to 17 Dec 2023
Phase
Phase 1
Are there results?
None posted in the registry

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 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body mass index of 17.5 to 38.0 kilograms per square meter (kg/m^2), inclusive, and total body weight >50 kg (110 pounds [lb]) at Screening.
  • Participants with a diagnosis of Parkinson's disease (PD) that is consistent with the United Kingdom (UK) Parkinson's Disease Society Brain Bank diagnostic criteria.
  • Must be modified Hoehn \& Yahr Stage I-III inclusive.
  • Must be on a stable dose of L-Dopa of at least 300 mg daily in conjunction with a dopa-decarboxylase inhibitor (e.g., L-Dopa/carbidopa, L Dopa/carbidopa/entacapone or L-Dopa/benserazide) administered at least 3 times per day for at least 2 weeks prior to the Day 1 Visit.

Who cannot join

  • Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supranuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or poststroke parkinsonism).
  • Participants with a history of psychosis or hallucinations within the previous 12 months.
  • Participants with epilepsy, or history of epilepsy, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), or who have increased risk of seizures as evidenced by history of electroencephalogram with epileptiform activity are excluded. Participants with a history of febrile seizures only are allowed with medical monitor approval.
  • History of substance or alcohol-use disorder (excluding nicotine; Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria) within 2 years prior to signing the informed consent form (ICF).
  • Participants who answer "Yes" on the C-SSRS Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 6 months, OR Participants who answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 6 months OR Participants who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide.
  • Participants who have attempted suicide in the past.
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  • Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at Screening.
  • Have been diagnosed with symptomatic coronavirus disease (COVID-19) or test positive (i.e., using polymerase chain reaction [PCR] or rapid antigen test) for COVID-19 within 30 days prior to signing the ICF.
  • Participants taking strong or moderate cytochrome P450 family 3 subfamily A member 4 (CYP3A4) inducers or inhibitors or who would be likely to require concomitant therapy with CYP3A4 inducers or inhibitors during the trial.
  • NOTE: Other protocol-defined inclusion and exclusion criteria may apply.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Decatur, Georgia

    Decatur, Georgia, 30030

  • Farmington Hills, Michigan

    Farmington Hills, Michigan, 48334

  • Hollywood, Florida

    Hollywood, Florida, 33024

  • Los Alamitos, California

    Los Alamitos, California, 90720

  • Orlando, Florida

    Orlando, Florida, 32806

  • South Miami, Florida

    South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Multiple-dose, Crossover Trial in Participants With Parkinson's Disease to Evaluate the Clinical Bioequivalence Between Tavapadon Tablets

The primary purpose of the study is to evaluate the bioequivalence (BE) of tavapadon 15 milligram (mg) tablet to 3x5 mg tablets in participants with Parkinson's disease.

Being tested
Tavapadon
Keywords
Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases, Dopamine Agonist, Dopamine Therapy
Medical subject headings
Parkinson Disease, Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases

What participants receive

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

  • TavapadonDrug

    Also called CVL-751, PF-06649751

    Oral tablets

Study groups in NCT05610189
Study groupRoleWhat they receive
Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mgExperimentalParticipants will receive tavapadon 1x15 mg tablet, orally, once daily (QD) from Day 15 to 21. Participants will receive tavapadon 3x5 mg tablets, orally, QD from Day 22 to 28.
Receives: Drug: Tavapadon
Cohort 2: Tavapadon 3x5 mg Followed by 1x15 mgExperimentalParticipants will receive tavapadon 3x5 mg tablets, orally, QD from Day 15 to 21. Participants will receive tavapadon 1x15 mg tablet, orally, QD from Day 22 to 28.
Receives: Drug: Tavapadon

What is being measured

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

  1. Maximum Observed Plasma Concentration (Cmax) of Tavapadon

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 28

  2. Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 28

Secondary outcomes (14)

  1. Minimum Steady-state Plasma Concentration (Cmin,ss) of Tavapadon

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 28

  2. Average Steady-state Plasma Concentration (Cavg,ss) of Tavapadon

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 28

  3. Trough Concentration (Ctrough) of Tavapadon

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 28

  4. Time of Maximum Observed Concentration (Tmax) of Tavapadon

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 28

  5. Degree of Fluctuation [(Cmax - Cmin)/Cavg,ss] of Tavapadon

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 28

  6. Peak-to-Trough Ratio (PTR) of Tavapadon

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 28

  7. Swing [(Cmax - Cmin)/Cmin,ss] of Tavapadon

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 28

  8. Apparent Clearance of Tavapadon From Plasma (CL/F)

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 28

  9. Number of Participants With Adverse Events (AEs) and AEs by Severity

    Measured: Up to Day 36

  10. Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values

    Measured: Up to Day 29

  11. Number of Participants With Clinically Significant Changes in Vital Sign Values

    Measured: Up to Day 29

  12. Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

    Measured: Up to Day 29

  13. Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results

    Measured: Up to Day 29

  14. Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)

    The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.

    Measured: Up to Day 29

Timeline

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

  1. First posted9 Nov 2022
  2. Study start15 Dec 2022
  3. Primary completion12 Dec 2023
  4. Study completion17 Dec 2023

Resources

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
Crossover
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05610189
Sponsor's protocol ID
CVL-751-1006
Status last verified
Feb 2024
First submitted
2 Nov 2022
Last updated
8 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tavapadon in people with Parkinson Disease, run by Cerevel Therapeutics, LLC at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Tavapadon (time frame: Pre-dose and at multiple timepoints post-dose up to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05610189.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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