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

NCT05404542 | Completed Phase 1 FDA Drug

• 1 other identifier: CVL-751-1004
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Renal Impairment

Keywords

Healthy Volunteer; Severe Renal 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 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 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 (2)

Severe Renal Impairment

EXPERIMENTAL

Participants with severe renal impairment will receive a single dose of tavapadon, 0.25 milligrams (mg) tablet, on Day 1.

Drug: Tavapadon

Normal Renal Function

EXPERIMENTAL

Participants with normal renal function will receive a single dose of tavapadon, 0.25 mg tablet, on Day 1.

Drug: Tavapadon

Interventions

Tavapadon DRUG

Oral tablets

Also known as: CVL-751

Normal Renal Function; Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cerevel Therapeutics, LLC: lead

Study Sites (3)

Jacksonville, Florida

Jacksonville, Florida, 32216, United States

Location

Miami, Florida

Miami, Florida, 33147, United States

Location

Tampa, Florida

Tampa, Florida, 33603, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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: May 10, 2022
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)