A Study of Orally Administered Pimodivir in Adult Participants With Renal Impairment

NCT03947814 | Terminated Phase 1

• 3 other identifiers: CR10861663623872FLZ10142018-002818-12
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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).

Conditions

Kidney Failure, Chronic

Keywords

Pimodivir,; JNJ-63623872,; Pharmacokinetics,; Renal impairment,; Kidney disease

Outcome Measures

Primary Outcomes (3)

• Maximum Observed concentration (Cmax) of Pimodivir

  Cmax is the maximum observed concentration.

  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

• Area Under Curve From Time of Dosing to the Time of the last Measurable Concentration (AUC[0-last]) of Pimodivir

  AUC(0-last) is the AUC from time of dosing to the time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.

  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

• AUC from time of dosing to infinity (AUC[0-infinity]) of Pimodivir

  AUC(0-infinity) is the AUC from time of dosing to infinity, calculated as AUC(0-last) + Clast/ (lambda\[z\]), where Clast is the last observed measurable concentration and lambda(z) is the apparent terminal elimination rate constant.

  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 (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Up to 42 (+/-) 2 days

Study Arms (4)

Part A: Normal renal function (control group)

EXPERIMENTAL

Participants with normal renal function (glomerular filtration rate \[GFR\] greater than or equal to \[\>=\] 90 milliliters per minute \[mL/min\]) will receive single oral dose of 600 mg pimodivir as 2\*300 mg tablets.

Drug: Pimodivir

Part A: Severe renal impairment or ESRD

EXPERIMENTAL

Participants with severe renal impairment (GFR \>=15 to less than \[\<\]30 mL/min) who are not on dialysis or end stage renal disease (ESRD) (GFR \<15 mL/min) not yet on dialysis will receive single oral dose of 600 mg pimodivir as 2\*300 mg tablets.

Drug: Pimodivir

Part B (Optional): Mild renal impairment

EXPERIMENTAL

Participants with mild renal impairment (GFR \>=60 mL/min to \<90 mL/min) will receive single oral dose of 600 mg pimodivir as 2\*300 mg tablets.

Drug: Pimodivir

Part B (Optional): Moderate renal impairment

EXPERIMENTAL

Participants with moderate renal impairment (GFR \>=30 to \<60 mL/min) will receive single oral dose of 600 mg pimodivir as 2\*300 mg tablets.

Drug: Pimodivir

Interventions

Pimodivir DRUG

Participants will receive single oral dose of 600 mg pimodivir as 2\*300 mg tablets.

Also known as: JNJ-63623872

Part A: Normal renal function (control group); Part A: Severe renal impairment or ESRD; Part B (Optional): Mild renal impairment; Part B (Optional): Moderate renal impairment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (2)

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

Location

APEX GmbH

München, 81241, Germany

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency; Kidney Diseases

Interventions

pimodivir

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 13, 2019
• Study Start: July 2, 2019
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)