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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: Tavapadon

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Jacksonville, Florida
    • Miami, Florida, United States, 33147
      • Miami, Florida
    • Tampa, Florida, United States, 33603
      • Tampa, Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

1. 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)].
2. 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.
3. Severe renal function: estimated glomerular filtration rate (eGFR) <30 mL/min (not requiring dialysis) determined using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
4. 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).
5. Stable concomitant medications for the management of individual participants medical history.

Key Exclusion Criteria:

1. Serious risk of suicide in the opinion of the investigator.
2. History of substance or alcohol use disorder (excluding nicotine or caffeine) within 12 months prior to signing the informed consent form (ICF).
3. Receipt of severe acute respiratory syndrome coronavirus 2(SARS-CoV2) vaccine or booster within 7 days of planned dosing.
4. 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.
5. Positive drug screen including tetrahydrocannabinol (THC).
6. 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.
7. Positive drug screen including THC (except with a vail prescription other than medical marijuana).
8. Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list.
9. Participants who require dialysis.
10. Participant with nephrotic syndrome.
11. Abnormal hemoglobin.
12. Abnormal blood pressure measurement or heart rate at Screening or Check-in.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Severe Renal Impairment; Participants with severe renal impairment will receive a single dose of tavapadon, 0.25 milligrams (mg) tablet, on Day 1.	Drug: Tavapadon; Oral tablets; Other Names: CVL-751
Experimental: Normal Renal Function; Participants with normal renal function will receive a single dose of tavapadon, 0.25 mg tablet, on Day 1.	Drug: Tavapadon; Oral tablets; Other Names: CVL-751

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Time 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 Outcome Measures

Outcome Measure	Time Frame
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)
Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score	Day 1 up to Follow-up (Day 15)

Collaborators and Investigators

• Sponsor: Cerevel Therapeutics, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): August 14, 2023

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Healthy Volunteer; Severe Renal Impairment
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency
• Other Study ID Numbers: CVL-751-1004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No