Status:
COMPLETED
To Evaluate Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function
Lead Sponsor:
Cerevel Therapeutics, LLC
Conditions:
Renal Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05404542
Start Date
May 10 2022
End Date
August 14 2023
Last Update
April 2 2024
Active Locations (3)
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1
Jacksonville, Florida
Jacksonville, Florida, United States, 32216
2
Miami, Florida
Miami, Florida, United States, 33147
3
Tampa, Florida
Tampa, Florida, United States, 33603