Status:
COMPLETED
To Evaluate the Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
Lead Sponsor:
Cerevel Therapeutics, LLC
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 impa...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05404529
Start Date
April 29 2022
End Date
January 24 2023
Last Update
May 30 2023
Active Locations (3)
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1
Miami, Florida
Miami, Florida, United States, 33014
2
Orlando, Florida
Orlando, Florida, United States, 32809
3
San Antonio, Texas
San Antonio, Texas, United States, 78215