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

Primary Purpose

Kidney Failure, Chronic

Status

Terminated

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Pimodivir

About this trial

This is an interventional other trial for Kidney Failure, Chronic focused on measuring Pimodivir,, JNJ-63623872,, Pharmacokinetics,, Renal impairment,, Kidney disease

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CRS Clinical Research Services Kiel GmbH
APEX GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

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

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Maximum Observed concentration (Cmax) of Pimodivir

Cmax is the maximum observed concentration.

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.

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT03947814

First Posted

May 10, 2019

Last Updated

July 1, 2022

Sponsor

Janssen-Cilag International NV

1. Study Identification

Unique Protocol Identification Number

NCT03947814

Brief Title

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

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

Study 63623872FLZ1014 was terminated early based on a strategic business decision by Janssen to end the clinical development program of JNJ-63623872.

Study Start Date

July 2, 2019 (Actual)

Primary Completion Date

September 9, 2020 (Actual)

Study Completion Date

September 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen-Cilag International NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure, Chronic

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A: Normal renal function (control group)

Arm Type

Experimental

Arm Description

Arm Title

Part A: Severe renal impairment or ESRD

Arm Type

Experimental

Arm Description

Arm Title

Part B (Optional): Mild renal impairment

Arm Type

Experimental

Arm Description

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.

Arm Title

Part B (Optional): Moderate renal impairment

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Pimodivir

Other Intervention Name(s)

JNJ-63623872

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum Observed concentration (Cmax) of Pimodivir

Description

Cmax is the maximum observed concentration.

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

Time Frame

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 Outcome Measure Information:

Title

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

Description

Time Frame

Up to 42 (+/-) 2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen-Cilag International NV Clinical Trial

Organizational Affiliation

Janssen-Cilag International NV

Official's Role

Study Director

Facility Information:

Facility Name

CRS Clinical Research Services Kiel GmbH

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

APEX GmbH

City

Munchen

ZIP/Postal Code

81241

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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