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OpenTrials
Completed

NCT Number: NCT05404542

To Evaluate Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function

The primary purpose is to assess the effect of renal impairment on the PK of tavapadon following administration of a single oral dose in participants with severe renal impairment relative to age, body weight, and sex-matched participants with normal renal function.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jacksonville, Florida, Jacksonville, 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 ≥18.0 to 40.0 kilograms per meter square (kg/m^2), inclusive, and a total body weight >50 kilograms (kg) [(110 pounds (lbs)].
  • Age that is within ±10 years of the median age for the severe renal impairment cohort. Bodyweight that is within ±15 kg of the median bodyweight for the severe renal impairment cohort.
  • Severe renal function: estimated glomerular filtration rate (eGFR) <30 mL/min (not requiring dialysis) determined using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  • Stable disease, defined as no clinically significant changes in disease status as documented by the most recent eGFR assessment (within at least 3 months before Screening).
  • Stable concomitant medications for the management of individual participants medical history.

Key Exclusion Criteria:

  • Serious risk of suicide in the opinion of the investigator.
  • History of substance or alcohol use disorder (excluding nicotine or caffeine) within 12 months prior to signing the informed consent form (ICF).
  • 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 ICF.
  • Positive drug screen including tetrahydrocannabinol (THC).
  • Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at Screening.
  • Positive drug screen including THC (except with a vail prescription other than medical marijuana).
  • Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list.
  • Participants who require dialysis.
  • Participant with nephrotic syndrome.
  • Abnormal hemoglobin.
  • Abnormal blood pressure measurement or heart rate at Screening or Check-in.

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 Time 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 Severe Renal Impairment Compared to Participants With Normal Renal Function

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2022
Registry last updated
Apr 2, 2024

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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