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OpenTrials
Completed

NCT Number: 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

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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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Miami, Florida, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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 Criteria:

  • 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.

Treatment and study plan

Tavapadon

Drug

Oral tablets

Other names: CVL-751

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Tavapadon

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

  2. Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Tavapadon

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

  3. Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon

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

Secondary outcomes

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

    Time frame: Day 1 up to Follow-up (Day 15)

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

    Time frame: Day 1 up to Follow-up (Day 15)

  3. Number of Participants with Clinically Significant Abnormalities in Vital Sign Values

    Time frame: Day 1 up to Follow-up (Day 15)

  4. Number of Participants with Clinically Significant Abnormalities in Laboratory Values

    Time frame: Day 1 up to Follow-up (Day 15)

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

    Time frame: Day 1 up to Follow-up (Day 15)

  6. Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score

    Time frame: Day 1 up to Follow-up (Day 15)

Sponsors and collaborators

Lead sponsor

Cerevel Therapeutics, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2022
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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