Clinical trial NCT05404542: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: Healthy Volunteer
Severe Renal Impairment
Lead sponsor: Cerevel Therapeutics, LLC
Sponsor class: INDUSTRY
First posted: 2022-06-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Tavapadon
timeFrame: pre-dose and at multiple timepoints post-dose up to Day 7
measure: Area Under the Plasma Concentration-time Curve from Time Zero to Time t (AUC0-t) of Tavapadon
timeFrame: pre-dose and at multiple timepoints post-dose up to Day 7
measure: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon
timeFrame: pre-dose and at multiple timepoints post-dose up to Day 7
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) and AEs by Severity
timeFrame: Day 1 up to Follow-up (Day 15)
measure: Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values
timeFrame: Day 1 up to Follow-up (Day 15)
measure: Number of Participants with Clinically Significant Abnormalities in Vital Sign Values
timeFrame: Day 1 up to Follow-up (Day 15)
measure: Number of Participants with Clinically Significant Abnormalities in Laboratory Values
timeFrame: Day 1 up to Follow-up (Day 15)
measure: Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results
timeFrame: Day 1 up to Follow-up (Day 15)
measure: Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Day 1 up to Follow-up (Day 15)
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Jacksonville, Florida
state: Florida
city: Miami
country: United States
facility: Miami, Florida
state: Florida
city: Tampa
country: United States
facility: Tampa, Florida
state: Florida
Study officials:
References: