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

Last updated: February 7, 2024
Sponsor: Cerevel Therapeutics, LLC
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Tavapadon

Clinical Study ID

NCT05610189
CVL-751-1006
  • Ages 45-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. 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).
  2. Participants with a history of psychosis or hallucinations within the previous 12months.
  3. Participants with epilepsy, or history of epilepsy, or conditions that lower seizurethreshold, seizures of any etiology (including substance or drug withdrawal), or whohave increased risk of seizures as evidenced by history of electroencephalogram withepileptiform activity are excluded. Participants with a history of febrile seizuresonly are allowed with medical monitor approval.
  4. History of substance or alcohol-use disorder (excluding nicotine; Diagnostic andStatistical Manual of Mental Disorders, 5th edition criteria) within 2 years prior tosigning the informed consent form (ICF).
  5. Participants who answer "Yes" on the C-SSRS Suicidal Ideation Item 4 (Active SuicidalIdeation with Some Intent to Act, Without Specific Plan) and whose most recent episodemeeting criteria for this C-SSRS Item 4 occurred within the last 6 months, ORParticipants who answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (Active SuicidalIdeation with Specific Plan and Intent) and whose most recent episode meeting criteriafor 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, interruptedattempt, aborted attempt, preparatory acts, or behavior) and whose most recent episodemeeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within thelast 2 years, OR Participants who, in the opinion of the investigator, present aserious risk of suicide.
  6. Participants who have attempted suicide in the past.
  7. Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surfaceantigen, hepatitis B core antibody, or hepatitis C antibody with detectable viralribonucleic acid (RNA) levels at Screening.
  8. 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-19within 30 days prior to signing the ICF.
  9. 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 therapywith CYP3A4 inducers or inhibitors during the trial. NOTE: Other protocol-defined inclusion and exclusion criteria may apply.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Tavapadon
Phase: 1
Study Start date:
December 15, 2022
Estimated Completion Date:
December 17, 2023

Connect with a study center

  • Los Alamitos, California

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Hollywood, Florida

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Orlando, Florida

    Orlando, Florida 32806
    United States

    Site Not Available

  • South Miami, Florida

    South Miami, Florida 33143
    United States

    Site Not Available

  • Decatur, Georgia

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Farmington Hills, Michigan

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.