Back to resultsTo Evaluate the Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
Primary Purpose
Hepatic Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tavapadon
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment focused on measuring Healthy Volunteer, Mild Hepatic Impairment, Moderate Hepatic Impairment
Eligibility Criteria
Key Inclusion Criteria:
- Body mass index of ≥17.5 to 42.0 0 kilograms per meter square (kg/m^2), inclusive, and a total body weight >50 kilograms (kg) [110 pounds (lbs)].
- Must meet the criteria for Class A or B of the modified Child-Pugh classification.
- Stable hepatic disease defined as no clinically significant change in disease status in the last 28 days prior to the screening visit.
- Previous alcohol abuse is permitted provided that the participant is willing and able to follow lifestyle guidelines and has a negative breath alcohol test at Screening and Check-in (Day -1).
Key Exclusion Criteria:
- Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine or booster within 7 days of planned dosing.
- Have recently been diagnosed with symptomatic Coronavirus Disease 2019 (COVID-19) or test positive for COVID-19 within 30 days prior to signing the informed consent form (ICF).
- Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.
- Has received study drug in a clinical trial of Tavapadon within 12 months of signing the ICF.
- Acute hepatitis.
- Grade ≥2 hepatic encephalopathy.
- Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list.
- Primary biliary cholangitis or primary sclerosing cholangitis.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Miami, Florida
- Orlando, Florida
- San Antonio, Texas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Moderate Hepatic Function
Mild Hepatic Function
Normal Hepatic Function
Arm Description
Participants will receive a single dose of tavapadon, 0.5 milligrams (mg) or 0.25 mg tablet based on tolerability, on Day 1.
Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1.
Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1.
Outcomes
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Tavapadon
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon
Secondary Outcome Measures
Number of Participants with Adverse Events (AEs) and AEs by Severity
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values
Number of Participants with Clinically Significant Abnormalities in Vital Sign Values
Number of Participants with Clinically Significant Abnormalities in Laboratory Values
Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results
Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05404529
Brief Title
To Evaluate the Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
Official Title
A Phase 1 Open-label Trial to Evaluate the Pharmacokinetics and Safety Following Single Dose of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
January 24, 2023 (Actual)
Study Completion Date
January 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerevel Therapeutics, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of the study is to assess the effect of hepatic impairment on the PK of tavapadon following administration of a single oral dose in participants with mild and moderate hepatic impairment relative to age, body weight, and sex-matched participants with normal hepatic function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
Keywords
Healthy Volunteer, Mild Hepatic Impairment, Moderate Hepatic Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderate Hepatic Function
Arm Type
Experimental
Arm Description
Participants will receive a single dose of tavapadon, 0.5 milligrams (mg) or 0.25 mg tablet based on tolerability, on Day 1.
Arm Title
Mild Hepatic Function
Arm Type
Experimental
Arm Description
Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1.
Arm Title
Normal Hepatic Function
Arm Type
Experimental
Arm Description
Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1.
Intervention Type
Drug
Intervention Name(s)
Tavapadon
Other Intervention Name(s)
CVL-751
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
Time Frame
pre-dose and at multiple timepoints post-dose up to Day 7
Title
Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Tavapadon
Time Frame
pre-dose and at multiple timepoints post-dose up to Day 7
Title
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon
Time Frame
pre-dose and at multiple timepoints post-dose up to Day 7
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs) and AEs by Severity
Time Frame
Day 1 up to Follow-up (Day 15)
Title
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values
Time Frame
Day 1 up to Follow-up (Day 15)
Title
Number of Participants with Clinically Significant Abnormalities in Vital Sign Values
Time Frame
Day 1 up to Follow-up (Day 15)
Title
Number of Participants with Clinically Significant Abnormalities in Laboratory Values
Time Frame
Day 1 up to Follow-up (Day 15)
Title
Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results
Time Frame
Day 1 up to Follow-up (Day 15)
Title
Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time Frame
Day 1 up to Follow-up (Day 15)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
Body mass index of ≥17.5 to 42.0 0 kilograms per meter square (kg/m^2), inclusive, and a total body weight >50 kilograms (kg) [110 pounds (lbs)].
Must meet the criteria for Class A or B of the modified Child-Pugh classification.
Stable hepatic disease defined as no clinically significant change in disease status in the last 28 days prior to the screening visit.
Previous alcohol abuse is permitted provided that the participant is willing and able to follow lifestyle guidelines and has a negative breath alcohol test at Screening and Check-in (Day -1).
Key Exclusion Criteria:
Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine or booster within 7 days of planned dosing.
Have recently been diagnosed with symptomatic Coronavirus Disease 2019 (COVID-19) or test positive for COVID-19 within 30 days prior to signing the informed consent form (ICF).
Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.
Has received study drug in a clinical trial of Tavapadon within 12 months of signing the ICF.
Acute hepatitis.
Grade ≥2 hepatic encephalopathy.
Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list.
Primary biliary cholangitis or primary sclerosing cholangitis.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Facility Information:
Facility Name
Miami, Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Orlando, Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
San Antonio, Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate the Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
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