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

Renal Impairment Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05404542
• Other study ID #: CVL-751-1004
• Status: Completed
• Phase: Phase 1
• Start date: May 10, 2022
• Est. completion date: August 14, 2023

Study information

• Verified date: April 2024
• Source: Cerevel Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• Tavapadon
Oral tablets

Locations

Country	Name	City	State
United States	Jacksonville, Florida	Jacksonville	Florida
United States	Miami, Florida	Miami	Florida
United States	Tampa, Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cerevel Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of Tavapadon		pre-dose and at multiple timepoints post-dose up to Day 7
Primary	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
Primary	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	Number of Participants with Adverse Events (AEs) and AEs by Severity		Day 1 up to Follow-up (Day 15)
Secondary	Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values		Day 1 up to Follow-up (Day 15)
Secondary	Number of Participants with Clinically Significant Abnormalities in Vital Sign Values		Day 1 up to Follow-up (Day 15)
Secondary	Number of Participants with Clinically Significant Abnormalities in Laboratory Values		Day 1 up to Follow-up (Day 15)
Secondary	Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results		Day 1 up to Follow-up (Day 15)
Secondary	Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score		Day 1 up to Follow-up (Day 15)