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

NCT ID: NCT05404542

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2023-08-14

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Severe Renal Impairment

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

Group Type: EXPERIMENTAL

Tavapadon

Intervention Type: DRUG

Oral tablets

Normal Renal Function

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

Group Type: EXPERIMENTAL

Tavapadon

Intervention Type: DRUG

Oral tablets

Interventions

Tavapadon

Oral tablets

Intervention Type: DRUG

Other Intervention Names

CVL-751

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cerevel Therapeutics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jacksonville, Florida

Jacksonville, Florida, United States

Miami, Florida

Miami, Florida, United States

Tampa, Florida

Tampa, Florida, United States

Countries

United States

Other Identifiers

CVL-751-1004

Identifier Type: -

Identifier Source: org_study_id