Renal Insufficiency
Conditions
Brief summary
The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult participants with various degrees of renal function (mildly, moderately, or severely impaired, or end-stage renal disease \[ESRD\] with or without hemodialysis) compared to adult participants with normal renal function.
Interventions
DRUGJNJ-64041575
All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250 mg tablets) on Day 1.
Sponsors
Janssen Pharmaceutica N.V., Belgium
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Participant must have a body mass index (BMI: body weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 36.0 kilogram per meter square (kg/m\^2), extremes included, and a body weight not less than 50.0 kg, inclusive, at screening * Contraceptive use by female participants, male participants and their female partners should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies if these are stricter than what is proposed in these inclusion criteria in the protocol Participants with normal renal function (Group 1): -Participant must have an estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute (mL/min) Participants with renal impairment (Groups 2 to 4): \- The following classifications of renal function are used: Mild renal impairment (eGFR greater than or equal to \[\>=\] 60 to less than \[\<\] 90 mL/min), Moderate renal impairment (eGFR \>= 30 to \<60 mL/min), Severe renal impairment (eGFR \>=15 to \<30 mL/min) Participants with end-stage renal disease (ESRD) with or without hemodialysis (Group 5): * Participant must have an eGFR \<15 mL/min if not on hemodialysis * Participant on hemodialysis treatment must have been on the same hemodialysis regimen for at least 3 months before screening
Exclusion criteria
All participants (Groups 1 to 5): * Participant has any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug (example, Crohn's disease), with the exception of renal impairment * Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * Participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs * Participant has known allergies, hypersensitivity, or intolerance to JNJ-64041575 or its excipients * Participants with evidence of an active infection * Participant is a woman who is pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose | The Cmax is the maximum observed plasma concentration. |
| Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC [0-last]) | Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose | The AUC (0-last) is the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration. |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC [0-infinity]) | Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose | The AUC (0-infinity) 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to 20 to 28 days after study drug intake (approximately 5 months) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
Countries
Germany
Outcome results
None listed