Back to resultsTo Evaluate Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function
Primary Purpose
Renal Impairment
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tavapadon
Sponsored by
About this trial
This is an interventional treatment trial for Renal Impairment focused on measuring Healthy Volunteer, Severe Renal Impairment
Eligibility Criteria
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.
Sites / Locations
- Jacksonville, Florida
- Miami, Florida
- Tampa, Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Severe Renal Impairment
Normal Renal Function
Arm Description
Participants with severe renal impairment will receive a single dose of tavapadon, 0.25 milligrams (mg) tablet, on Day 1.
Participants with normal renal function will receive a single dose of tavapadon, 0.25 mg tablet, on Day 1.
Outcomes
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
Area Under the Plasma Concentration-time Curve from Time Zero to Time t (AUC0-t) of Tavapadon
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon
Secondary Outcome Measures
Number of Participants with Adverse Events (AEs) and AEs by Severity
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values
Number of Participants with Clinically Significant Abnormalities in Vital Sign Values
Number of Participants with Clinically Significant Abnormalities in Laboratory Values
Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results
Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05404542
Brief Title
To Evaluate Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerevel Therapeutics, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
Healthy Volunteer, Severe Renal Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Severe Renal Impairment
Arm Type
Experimental
Arm Description
Participants with severe renal impairment will receive a single dose of tavapadon, 0.25 milligrams (mg) tablet, on Day 1.
Arm Title
Normal Renal Function
Arm Type
Experimental
Arm Description
Participants with normal renal function will receive a single dose of tavapadon, 0.25 mg tablet, on Day 1.
Intervention Type
Drug
Intervention Name(s)
Tavapadon
Other Intervention Name(s)
CVL-751
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
Time Frame
pre-dose and at multiple timepoints post-dose up to Day 7
Title
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
Title
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 Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs) and AEs by Severity
Time Frame
Day 1 up to Follow-up (Day 15)
Title
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values
Time Frame
Day 1 up to Follow-up (Day 15)
Title
Number of Participants with Clinically Significant Abnormalities in Vital Sign Values
Time Frame
Day 1 up to Follow-up (Day 15)
Title
Number of Participants with Clinically Significant Abnormalities in Laboratory Values
Time Frame
Day 1 up to Follow-up (Day 15)
Title
Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results
Time Frame
Day 1 up to Follow-up (Day 15)
Title
Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time Frame
Day 1 up to Follow-up (Day 15)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Jacksonville, Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Miami, Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
Tampa, Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function
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