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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-29

Study Completion Date

2023-01-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moderate Hepatic Function

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

Group Type EXPERIMENTAL

Tavapadon

Intervention Type DRUG

Oral tablets

Mild Hepatic Function

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

Group Type EXPERIMENTAL

Tavapadon

Intervention Type DRUG

Oral tablets

Normal Hepatic Function

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

Group Type EXPERIMENTAL

Tavapadon

Intervention Type DRUG

Oral tablets

Interventions

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Tavapadon

Oral tablets

Intervention Type DRUG

Other Intervention Names

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CVL-751

Eligibility Criteria

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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).

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes