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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03947814
Recruitment Status : Terminated (Strategic decision to stop pimodivir phase 1 studies)
First Posted : May 13, 2019
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

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).

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: Pimodivir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : July 2, 2019
Actual Primary Completion Date : September 9, 2020
Actual Study Completion Date : September 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
Experimental: Part A: Normal renal function (control group)
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
Participants will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets.
Other Name: JNJ-63623872

Experimental: Part A: Severe renal impairment or ESRD
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
Participants will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets.
Other Name: JNJ-63623872

Experimental: Part B (Optional): Mild renal impairment
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
Participants will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets.
Other Name: JNJ-63623872

Experimental: Part B (Optional): Moderate renal impairment
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
Participants will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets.
Other Name: JNJ-63623872




Primary Outcome Measures :
  1. Maximum Observed concentration (Cmax) of Pimodivir [ 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 ]
    Cmax is the maximum observed concentration.

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

  3. AUC from time of dosing to infinity (AUC[0-infinity]) of Pimodivir [ 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 ]
    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 :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 42 (+/-) 2 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947814


Locations
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Germany
CRS Clinical Research Services Kiel GmbH
Kiel, Germany, 24105
APEX GmbH
Munchen, Germany, 81241
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
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Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
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Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT03947814    
Other Study ID Numbers: CR108616
63623872FLZ1014 ( Other Identifier: Janssen-Cilag International NV )
2018-002818-12 ( EudraCT Number )
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen-Cilag International NV:
Pimodivir,
JNJ-63623872,
Pharmacokinetics,
Renal impairment,
Kidney disease
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic