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

NCT ID: NCT05610189

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2023-12-17

Brief 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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mg

Participants 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.

Group Type: EXPERIMENTAL

Tavapadon

Intervention Type: DRUG

Oral tablets

Cohort 2: Tavapadon 3x5 mg Followed by 1x15 mg

Participants 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.

Group Type: EXPERIMENTAL

Tavapadon

Intervention Type: DRUG

Oral tablets

Interventions

Tavapadon

Oral tablets

Intervention Type: DRUG

Other Intervention Names

CVL-751; PF-06649751

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

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 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.

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 12 months.

3. 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.

4. 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).

5. 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.

6. Participants who have attempted suicide in the past.

7. 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.

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-19 within 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 therapy with CYP3A4 inducers or inhibitors during the trial.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cerevel Therapeutics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Los Alamitos, California

Los Alamitos, California, United States

Hollywood, Florida

Hollywood, Florida, United States

Orlando, Florida

Orlando, Florida, United States

South Miami, Florida

South Miami, Florida, United States

Decatur, Georgia

Decatur, Georgia, United States

Farmington Hills, Michigan

Farmington Hills, Michigan, United States

Countries

United States

Other Identifiers

CVL-751-1006

Identifier Type: -

Identifier Source: org_study_id