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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2024
• Main ID: NCT05610189
• Date of registration: 02/11/2022
• Prospective Registration: Yes
• Primary sponsor: Cerevel Therapeutics, LLC
• Public title: Multiple-dose Trial to Determine the Clinical Bioequivalence Between Tavapadon Tablets in Participants With Parkinson's Disease
• Scientific title: A Phase 1, Randomized, Multiple-dose, Crossover Trial in Participants With Parkinson's Disease to Evaluate the Clinical Bioequivalence Between Tavapadon Tablets
• Date of first enrolment: December 15, 2022
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT05610189
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion 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.

NOTE: Other protocol-defined inclusion and exclusion criteria may apply.



Age minimum: 45 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Tavapadon

Primary Outcome(s)

Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCt) of Tavapadon [Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 28]

Maximum Observed Plasma Concentration (Cmax) of Tavapadon [Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 28]

Secondary Outcome(s)

Time of Maximum Observed Concentration (Tmax) of Tavapadon [Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 28]

Average Steady-state Plasma Concentration (Cavg,ss) of Tavapadon [Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 28]

Apparent Clearance of Tavapadon From Plasma (CL/F) [Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 28]

Swing [(Cmax - Cmin)/Cmin,ss] of Tavapadon [Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 28]

Degree of Fluctuation [(Cmax - Cmin)/Cavg,ss] of Tavapadon [Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 28]

Minimum Steady-state Plasma Concentration (Cmin,ss) of Tavapadon [Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 28]

Number of Participants With Adverse Events (AEs) and AEs by Severity [Time Frame: Up to Day 36]

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments [Time Frame: Up to Day 29]

Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values [Time Frame: Up to Day 29]

Peak-to-Trough Ratio (PTR) of Tavapadon [Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 28]

Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) [Time Frame: Up to Day 29]

Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results [Time Frame: Up to Day 29]

Number of Participants With Clinically Significant Changes in Vital Sign Values [Time Frame: Up to Day 29]

Trough Concentration (Ctrough) of Tavapadon [Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 28]

Secondary ID(s)

CVL-751-1006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors