Renal Insufficiency
Conditions
Brief summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of AL-335 in participants with various degrees of impaired renal function (mild, moderate, and severe) compared to participants with normal renal function.
Interventions
DRUGAL-335
Participants with various degrees of impaired renal function (mild \[Cohort 1\], moderate \[Cohort 2\], severe \[Cohort 3\]) and normal renal function (Cohort 4) will receive a single oral dose of AL-335 800 mg (given as 2\*400-mg tablets).
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Cohorts 1-4: * Participant must have a body mass index (BMI; weight in kilogram (kg) divided by the square of height in meters) of 18 to 36 kilogram per meter square (kg/m\^2), extremes included, and a body weight not less than 50.0 kg * Participants must agree to follow all requirements that must be met during the study as noted in the Inclusion and
Exclusion criteria
(eg, contraceptive requirements) * Female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after study drug administration * Male participant must agree not to donate sperm from enrollment (Day 1) in the study until at least 30 days after receiving the study drug Cohorts 1-3: * Participant must have stable renal function * Participant must be otherwise healthy except for the renal impairment and its underlying disease states and mild comorbidities and participant must be medically stable on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening * Participants must have an estimated glomerular filtration rate (eGFR) less than (\<) 90 milliLiter per minute per 1.73 meter square (mL/min/1.73m\^2). Mild renal impairment (eGFR 60 to \<90 mL/min/1.73m\^2); moderate renal impairment (eGFR 30 to \<60 mL/min/1.73m\^2); severe renal impairment (eGFR \<30 mL/min/1.73m\^2 not requiring dialysis) Cohort 4: * Participant must be healthy on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical laboratory tests performed at screening * Participants must have an eGFR greater than or equal to (\>=) 90 mL/min/1.73m\^2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose | The AUClast is the area under the analyte (AL-335) concentration-time curve from time zero (0) to time of the last quantifiable concentration. |
| Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUCinfinity) | Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose | The AUCinfinity is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. |
| Maximum Observed Concentration (Cmax) of AL-335 | Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose | The Cmax is the maximum observed concentration of analyte (AL-335). |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to follow-up (Approximately 30-35 days after study drug administration) |
Countries
United States
Outcome results
None listed