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

NCT05610189 | Completed Phase 1 FDA Drug

• 1 other identifier: CVL-751-1006
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

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

Keywords

Parkinsonian Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Dopamine Agonist; Dopamine Therapy

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax) of Tavapadon

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

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

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

Secondary Outcomes (14)

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

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

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

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

• Trough Concentration (Ctrough) of Tavapadon

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

• Time of Maximum Observed Concentration (Tmax) of Tavapadon

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

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

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

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Tavapadon

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

EXPERIMENTAL

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.

Drug: Tavapadon

Interventions

Tavapadon DRUG

Oral tablets

Also known as: CVL-751, PF-06649751

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

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cerevel Therapeutics, LLC: lead

Study Sites (6)

Los Alamitos, California

Los Alamitos, California, 90720, United States

Location

Hollywood, Florida

Hollywood, Florida, 33024, United States

Location

Orlando, Florida

Orlando, Florida, 32806, United States

Location

South Miami, Florida

South Miami, Florida, 33143, United States

Location

Decatur, Georgia

Decatur, Georgia, 30030, United States

Location

Farmington Hills, Michigan

Farmington Hills, Michigan, 48334, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Synucleinopathies

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 9, 2022
• Study Start: December 15, 2022
• Primary Completion: December 12, 2023
• Study Completion: December 17, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)