To Evaluate the Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function

Hepatic Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05404529
• Other study ID #: CVL-751-1003
• Status: Completed
• Phase: Phase 1
• Start date: April 29, 2022
• Est. completion date: January 24, 2023

Study information

• Verified date: May 2023
• Source: Cerevel Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 24, 2023
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Tavapadon
Oral tablets

Locations

Country	Name	City	State
United States	Miami, Florida	Miami	Florida
United States	Orlando, Florida	Orlando	Florida
United States	San Antonio, Texas	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cerevel Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of Tavapadon		pre-dose and at multiple timepoints post-dose up to Day 7
Primary	Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Tavapadon		pre-dose and at multiple timepoints post-dose up to Day 7
Primary	Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon		pre-dose and at multiple timepoints post-dose up to Day 7
Secondary	Number of Participants with Adverse Events (AEs) and AEs by Severity		Day 1 up to Follow-up (Day 15)
Secondary	Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values		Day 1 up to Follow-up (Day 15)
Secondary	Number of Participants with Clinically Significant Abnormalities in Vital Sign Values		Day 1 up to Follow-up (Day 15)
Secondary	Number of Participants with Clinically Significant Abnormalities in Laboratory Values		Day 1 up to Follow-up (Day 15)
Secondary	Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results		Day 1 up to Follow-up (Day 15)
Secondary	Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score		Day 1 up to Follow-up (Day 15)