Clinical trial NCT05404529: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Healthy Volunteer
Mild Hepatic Impairment
Moderate Hepatic Impairment
Lead sponsor: Cerevel Therapeutics, LLC
Sponsor class: INDUSTRY
First posted: 2022-06-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

1. 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) \[110 pounds (lbs)\].
2. Must meet the criteria for Class A or B of the modified Child-Pugh classification.
3. Stable hepatic disease defined as no clinically significant change in disease status in the last 28 days prior to the screening visit.
4. 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:

1. Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine or booster within 7 days of planned dosing.
2. 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).
3. Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.
4. Has received study drug in a clinical trial of Tavapadon within 12 months of signing the ICF.
5. Acute hepatitis.
6. Grade ≥2 hepatic encephalopathy.
7. Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list.
8. Primary biliary cholangitis or primary sclerosing cholangitis.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Tavapadon
timeFrame: pre-dose and at multiple timepoints post-dose up to Day 7
measure: Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Tavapadon
timeFrame: pre-dose and at multiple timepoints post-dose up to Day 7
measure: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon
timeFrame: pre-dose and at multiple timepoints post-dose up to Day 7
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) and AEs by Severity
timeFrame: Day 1 up to Follow-up (Day 15)
measure: Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values
timeFrame: Day 1 up to Follow-up (Day 15)
measure: Number of Participants with Clinically Significant Abnormalities in Vital Sign Values
timeFrame: Day 1 up to Follow-up (Day 15)
measure: Number of Participants with Clinically Significant Abnormalities in Laboratory Values
timeFrame: Day 1 up to Follow-up (Day 15)
measure: Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results
timeFrame: Day 1 up to Follow-up (Day 15)
measure: Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Day 1 up to Follow-up (Day 15)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami, Florida
state: Florida
city: Orlando
country: United States
facility: Orlando, Florida
state: Florida
city: San Antonio
country: United States
facility: San Antonio, Texas
state: Texas
Study officials:
References: