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

NCT05404529 | Completed Phase 1 FDA Drug

• 1 other identifier: CVL-751-1003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatic Impairment

Keywords

Healthy Volunteer; Mild Hepatic Impairment; Moderate Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of Tavapadon

  pre-dose and at multiple timepoints post-dose up to Day 7

• 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

• 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 Outcomes (6)

• Number of Participants with Adverse Events (AEs) and AEs by Severity

  Day 1 up to Follow-up (Day 15)

• Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values

  Day 1 up to Follow-up (Day 15)

• Number of Participants with Clinically Significant Abnormalities in Vital Sign Values

  Day 1 up to Follow-up (Day 15)

• Number of Participants with Clinically Significant Abnormalities in Laboratory Values

  Day 1 up to Follow-up (Day 15)

• Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results

  Day 1 up to Follow-up (Day 15)

Study Arms (3)

Moderate Hepatic Function

EXPERIMENTAL

Participants will receive a single dose of tavapadon, 0.5 milligrams (mg) or 0.25 mg tablet based on tolerability, on Day 1.

Drug: Tavapadon

Mild Hepatic Function

EXPERIMENTAL

Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1.

Drug: Tavapadon

Normal Hepatic Function

EXPERIMENTAL

Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1.

Drug: Tavapadon

Interventions

Tavapadon DRUG

Oral tablets

Also known as: CVL-751

Mild Hepatic Function; Moderate Hepatic Function; Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cerevel Therapeutics, LLC: lead

Study Sites (3)

Miami, Florida

Miami, Florida, 33014, United States

Location

Orlando, Florida

Orlando, Florida, 32809, United States

Location

San Antonio, Texas

San Antonio, Texas, 78215, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 3, 2022
• Study Start: April 29, 2022
• Primary Completion: January 24, 2023
• Study Completion: January 24, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)