Clinical trial NCT03947814: A Study of Orally Administered Pimodivir in Adult Participants With Renal Impairment
Official title: A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Pimodivir in Adult Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Kidney Failure, Chronic
Keywords: Pimodivir,
JNJ-63623872,
Pharmacokinetics,
Renal impairment,
Kidney disease
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2019-05-13
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics (PK) of pimodivir after a single oral dose of 600 milligrams (mg) in adult participants with severe renal impairment who are not on dialysis and in adult participants with end-stage renal disease (ESRD) who are not yet on dialysis compared to adult participants with normal renal function (Part A). Optionally, to evaluate the PK in adult participants with mild and/or moderate renal impairment compared to adult participants with normal renal function (Part B).


Eligibility criteria: Inclusion Criteria:

* Participant must have a body mass index (Body Mass Index \[BMI\]; body weight (Kilograms per height\^2 \[kg/m\^2\]) between 18.0 and 38.0 kg/m\^2, inclusive, and body weight not less than 50 kg, inclusive, at screening
* Participants with normal renal function must have normal values for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (less than or equal to \[\<=\]1.5\*upper limit of laboratory normal range \[ULN\]) at screening and Day -1 and participants with renal impairment and end-stage renal disease (ESRD) must have values for ALT and AST \<=3.0\*ULN at screening and Day -1
* Participants with normal renal function must have glomerular filtration rate (GFR) greater than or equal to (\>=) 90 milliliters per minute (mL/min) and participants with renal impairment (mild, moderate and severe) and ESRD must have \>=60 mL/min to \<90 mL/min (for Mild renal impairment); \>=30 to \<60 mL/min (for Moderate renal impairment); \>=15 mL/min to \<30 mL/min (for Severe renal impairment not on dialysis); and \<15 mL/min (for ESRD not on dialysis)
* Participants with normal renal function must have a systolic blood pressure (after the participant is supine for 5 minutes) between 90 millimeters of mercury (mmHg), extremes included, and diastolic blood pressure no higher than 90 mmHg and participants with renal impairment (mild, moderate and severe) and ESRD must have a systolic blood pressure (after the participant is supine for 5 minutes) between 90 and 159 mmHg, extremes included, and diastolic blood pressure no higher than 99 mmHg. If blood pressure is out of range, 1 repeated assessment is permitted after an additional 5 minutes of rest
* A woman, except if postmenopausal, must have a negative highly sensitive serum pregnancy test (beta human chorionic gonadotropin \[beta hCG\]) at screening and a negative urine pregnancy test on Day -1

Exclusion Criteria:

* Participant has any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug (for example \[e.g.\], Crohn's disease), with the exception of renal impairment
* Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or any other clinically active liver disease at screening
* Participant has a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillin, or drug allergy diagnosed in previous studies with experimental drugs
* Participant has known allergies, hypersensitivity, or intolerance to pimodivir or its excipients
* Participant has evidence of an active infection

Primary outcomes:
measure: Maximum Observed concentration (Cmax) of Pimodivir
timeFrame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 6
measure: Area Under Curve From Time of Dosing to the Time of the last Measurable Concentration (AUC[0-last]) of Pimodivir
timeFrame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 6
measure: AUC from time of dosing to infinity (AUC[0-infinity]) of Pimodivir
timeFrame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 6
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 42 (+/-) 2 days
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: CRS Clinical Research Services Kiel GmbH
city: Munchen
country: Germany
facility: APEX GmbH
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References: