Kidney Failure, ChronicPhase 1NCT03947814

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

A Phase 1 study testing Pimodivir in people with Kidney Failure, Chronic, run by Janssen-Cilag International NV at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Kidney Failure, Chronic
What is being tested?: Pimodivir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 2 sitesGermany
Study dates: 2 Jul 2019to 9 Sep 2020
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

CRS Clinical Research Services Kiel GmbH
Kiel, 24105
APEX GmbH
München, 81241

Other trials in Germany

About this study

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

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
Being tested: Pimodivir
Keywords: Pimodivir,, JNJ-63623872,, Pharmacokinetics,, Renal impairment,, Kidney disease
Medical subject headings: Kidney Failure, Chronic, Renal Insufficiency, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PimodivirDrug
Also called JNJ-63623872
Participants will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets.

Study groups in NCT03947814
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Pimodivir

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed concentration (Cmax) of Pimodivir
Cmax is the maximum observed concentration.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Up to 42 (+/-) 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 20199 Sep 2020

First posted13 May 2019
Study start2 Jul 2019
Primary completion9 Sep 2020
Study completion9 Sep 2020

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

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03947814
Sponsor's protocol ID: CR108616
Other IDs: 63623872FLZ1014, 2018-002818-12, 2018
Status last verified: Jan 2025
First submitted: 10 May 2019
Last updated: 3 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03947814
Acronym / sponsor ID: CR108616
Conditions: Kidney Failure, Chronic
Keywords: Pimodivir,, JNJ-63623872,, Pharmacokinetics,, Renal impairment,, Kidney disease
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study 63623872FLZ1014 was terminated early based on a strategic business decision by Janssen to end the clinical development program of JNJ-63623872.
Enrolment: 29 participants (actual)
Lead sponsor: Janssen-Cilag International NVIndustry (pharma, biotech, devices)
Study start: 2 Jul 2019 (actual)
Primary completion: 9 Sep 2020 (actual)
Study completion: 9 Sep 2020 (actual)
First posted: 13 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Part A: Normal renal function (control group)	Experimental	Drug: PimodivirParticipants 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.
Part A: Severe renal impairment or ESRD	Experimental	Drug: PimodivirParticipants 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.
Part B (Optional): Mild renal impairment	Experimental	Drug: PimodivirParticipants 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.
Part B (Optional): Moderate renal impairment	Experimental	Drug: PimodivirParticipants with moderate renal impairment (GFR >=30 to <60 mL/min) will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PimodivirAlso: JNJ-63623872Participants will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets.	Drug	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

Primary outcome

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.
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.
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.

1 secondary outcome

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 42 (+/-) 2 days

Results and safety

The study was stopped early (reason given: Study 63623872FLZ1014 was terminated early based on a strategic business decision by Janssen to end the clinical development program of JNJ-63623872.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Individual participant dataSharing planned: Yes. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen-Cilag International NV Clinical Trial study director

Janssen-Cilag International NV

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pimodivir in people with Kidney Failure, Chronic, run by Janssen-Cilag International NV at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03947814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.