Renal ImpairmentPhase 1NCT04037865

A Renal Impairment Study for PF-06651600

A Phase 1 study testing PF-06651600 in people with Renal Impairment, run by Pfizer at 3 sites in United States.

Terminated

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

Trial summary

This is a Phase 1 non-randomized, open-label, parallel cohort study of PF-06651600 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with mild and moderate renal impairment (Part 2). Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: PF-06651600
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 3 sitesUnited States
Study dates: 19 Aug 2019to 31 Mar 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Body mass index (BMI) of >/= 17.5 to </= 40.0 kg/m2; and a total body weight > 50 kg (110 lb)
Additional inclusion criteria for subjects with renal impairment:
Meet the following eGFR criteria during the screening period based upon MDRD equation:
Severe renal impairment: eGFR <30 mL/min but not requiring hemodialysis
Moderate renal impairment (Part 2 only): eGFR >/=30 mL/min and <60 mL/min
Mild renal impairment (Part 2 only): eGFR between 60 and 89 mL/min
Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included)
Stable drug regimen

Who cannot join

Females of child-bearing potential must use an accepted, highly effective contraceptive method
Renal transplant recipients
Urinary incontinence without catheterization
Subjects with clinically significant infections within the past 6 months prior to first dose of study drug, evidence of active or chronic infection requiring oral treatment within 4 weeks prior, history of disseminated herpes simplex or recurrent or disseminated herpes zoster
Subjects with malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of skin or cervical carcinoma in situ
HIV, Hepatitis B, or Hepatitis C infection

Show all 10Show fewer

Additional exclusion criteria for subjects with renal impairment:
Subjects requiring hemodialysis and peritoneal dialysis
Screening BP >/=180 mmHg (systolic) or >/=110 mmHg (diastolic)
Screening 12-lead ECG demonstrating QTcF >470 msec

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Investigational Drug Services (IDS) University of Miami Hospitals and Clinics
Miami, Florida, 33136
University of Miami Division of Clinical Pharmacology
Miami, Florida, 33136
Prism Clinical Research, LLC
Saint Paul, Minnesota, 55114

Other trials in United States

About this study

Official title: A PHASE 1, NON-RANDOMIZED, OPEN LABEL, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF 06651600 IN PARTICIPANTS WITH RENAL IMPAIRMENT AND IN HEALTHY PARTICIPANTS WITH NORMAL RENAL FUNCTION

Read the detailed description

This is a Phase 1 non-randomized, open-label, parallel cohort, multi-site study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-06651600 after multiple oral doses of 50 mg daily. Subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: A total of approximately 16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. After statistical evaluation of results from Part 1, Part 2 may be conducted with approximately 8 subjects each with moderate and mild renal impairment. The total duration of participation from Screening visit to Day 11 will be a maximum of 39 days and from Screening visit to Follow-up/Contact Visit will a maximum of 73 days.

Conditions: Renal Impairment
Being tested: PF-06651600
Medical subject headings: Renal Insufficiency

What participants receive

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

PF-06651600Drug
PF-06651600 50 mg oral tablets will be administered on Days 1 to 10

Study groups in NCT04037865
Study group	Role	What they receive
PF-06651600 Severe Renal Impairment	Experimental	This arm includes participants with severe renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10 Receives: Drug: PF-06651600
PF-06651600 Normal Renal Function	Experimental	This arm includes participants with normal renal function who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10 Receives: Drug: PF-06651600
PF-06651600 Moderate Renal Impairment	Experimental	This arm is in Part 2 which will be conducted if decision criterion to proceed to Part 2 is met. This arm includes participants with moderate renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10 Receives: Drug: PF-06651600
PF-06651600 Mild Renal Impairment	Experimental	This arm is in Part 2 which will be conducted if the decision criterion to proceed to Part 2 is met. The arm includes participants with mild renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10. Receives: Drug: PF-06651600

What is being measured

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

Plasma PF-06651600 Maximum Plasma Concentration (Cmax)
The plasma PF-06651600 Cmax was observed directly from data.
Measured: On Day 8 and Day 9 predose, and at 0 (predose), 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 hours after dose on Day 10, and 24 hours after dose on Day 11.
Plasma PF-06651600 Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
Plasma PF-06651600 AUC0-24 was determined using a linear/log trapezoidal method.
Measured: On Day 8 and Day 9 predose, and at 0 (predose), 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 hours after dose on Day 10, and 24 hours after dose on Day 11.

Secondary outcomes (4)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE is considered a TEAE is the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs. An AE was considered treatment-related if the causality of the AE was assessed to be the investigational product. The causality of AEs was assessed by the investigator using clinical judgment.
Measured: From Screening (Day -28) through and including up to 35 calendar days after the last administration of investigational product, assessed up to 74 days.
Number of Participants With Laboratory Abnormalities
Safety laboratory assessments include clinical chemistry, hematology and urinalysis. Serum creatinine was only assessed on Screening visit 2 and on Day 2 and Day 8 for eGFR assessment. The number of participants with laboratory test abnormalities without regard to baseline abnormality was reported.
Measured: At Screening Visit 1 and on Days -1, 5, 11 and early termination day.
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Vital signs evaluations included supine blood pressure (BP), pulse rate, and temperature. Criteria for vital signs values included: supine diastolic BP >= 20 mmHg increase from baseline, supine systolic BP >= 30 mmHg increase from baseline, supine diastolic BP >= 20 mmHg decrease from baseline, and supine systolic BP >= 30 mmHg decrease from baseline.
Measured: At screening, on Day 1, Day 5, Day 11 and early termination/discontinuation.
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
ECG criteria included PR, QT, and QTc intervals and QRS complex. Participants with absolute data value meeting the following criteria were reported: aggregate PR interval value >= 300 msec, aggregate QRS duration value >= 140 msec, absolute QTcF interval value >450 msec and <= 480 msec, or >480 msec and <=500 msec, or >500 msec.
Measured: At screening, on Day -1, Day 11 and early termination/discontinuation.

Timeline

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

19 Aug 201931 Mar 2020

First posted30 Jul 2019
Study start19 Aug 2019
Primary completion31 Mar 2020
Study completion31 Mar 2020

Why it stopped: The study was terminated due to extensive Covid-19 delay.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Renal ImpairmentStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04037865
Sponsor's protocol ID: B7981020
Status last verified: Apr 2021
First submitted: 26 Jul 2019
Last updated: 18 May 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.
PubMed 37917289
Purohit V, Huh Y, Wojciechowski J, Plotka A, Salts S, Antinew J, Dimitrova A, Nicholas T. Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics. AAPS J. 2023 Mar 28;25(3):32. doi: 10.1208/s12248-023-00792-8.
PubMed 36977960

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?

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, NON-RANDOMIZED, OPEN LABEL, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF 06651600 IN PARTICIPANTS WITH RENAL IMPAIRMENT AND IN HEALTHY PARTICIPANTS WITH NORMAL RENAL FUNCTION
ClinicalTrials.gov ID: NCT04037865
Acronym / sponsor ID: B7981020
Conditions: Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated due to extensive Covid-19 delay.
Enrolment: 8 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 19 Aug 2019 (actual)
Primary completion: 31 Mar 2020 (actual)
Study completion: 31 Mar 2020 (actual)
First posted: 30 Jul 2019 (actual)
Results: Posted 18 May 2021

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
PF-06651600 Severe Renal Impairment	Experimental	Drug: PF-06651600This arm includes participants with severe renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
PF-06651600 Normal Renal Function	Experimental	Drug: PF-06651600This arm includes participants with normal renal function who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
PF-06651600 Moderate Renal Impairment	Experimental	Drug: PF-06651600This arm is in Part 2 which will be conducted if decision criterion to proceed to Part 2 is met. This arm includes participants with moderate renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
PF-06651600 Mild Renal Impairment	Experimental	Drug: PF-06651600This arm is in Part 2 which will be conducted if the decision criterion to proceed to Part 2 is met. The arm includes participants with mild renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Body mass index (BMI) of >/= 17.5 to </= 40.0 kg/m2; and a total body weight > 50 kg (110 lb)
Meet the following eGFR criteria during the screening period based upon MDRD equation:
Severe renal impairment: eGFR <30 mL/min but not requiring hemodialysis
Moderate renal impairment (Part 2 only): eGFR >/=30 mL/min and <60 mL/min
Mild renal impairment (Part 2 only): eGFR between 60 and 89 mL/min

Key exclusion criteria (10 listed)

Females of child-bearing potential must use an accepted, highly effective contraceptive method
Renal transplant recipients
Urinary incontinence without catheterization
Subjects with clinically significant infections within the past 6 months prior to first dose of study drug, evidence of active or chronic infection requiring oral treatment within 4 weeks prior, history of disseminated herpes simplex or recurrent or disseminated herpes zoster
Subjects with malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of skin or cervical carcinoma in situ

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
PF-06651600PF-06651600 50 mg oral tablets will be administered on Days 1 to 10	Drug	PF-06651600 Mild Renal Impairment, PF-06651600 Moderate Renal Impairment, PF-06651600 Normal Renal Function, PF-06651600 Severe Renal Impairment

Primary outcome

Plasma PF-06651600 Maximum Plasma Concentration (Cmax)
Time frame: On Day 8 and Day 9 predose, and at 0 (predose), 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 hours after dose on Day 10, and 24 hours after dose on Day 11.
The plasma PF-06651600 Cmax was observed directly from data.
Plasma PF-06651600 Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
Time frame: On Day 8 and Day 9 predose, and at 0 (predose), 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 hours after dose on Day 10, and 24 hours after dose on Day 11.
Plasma PF-06651600 AUC0-24 was determined using a linear/log trapezoidal method.

4 secondary outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From Screening (Day -28) through and including up to 35 calendar days after the last administration of investigational product, assessed up to 74 days.
Number of Participants With Laboratory Abnormalities
Time frame: At Screening Visit 1 and on Days -1, 5, 11 and early termination day.
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Time frame: At screening, on Day 1, Day 5, Day 11 and early termination/discontinuation.
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
Time frame: At screening, on Day -1, Day 11 and early termination/discontinuation.

Results and safety

Results posted to the registry on 18 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Severe Renal Impairment	8	8

Primary outcome: Plasma PF-06651600 Maximum Plasma Concentration (Cmax)

Time frame: On Day 8 and Day 9 predose, and at 0 (predose), 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 hours after dose on Day 10, and 24 hours after dose on Day 11.. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Severe Renal Impairment n = 8
Value	445.6 (21)

Population analysed: The analysis population included all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest.

Primary outcome: Plasma PF-06651600 Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)

Measure	Severe Renal Impairment n = 8
Value	986.3 (33)

Population analysed: The analysis population included all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Screening (Day -28) through and including up to 35 calendar days after the last administration of investigational product, assessed up to 74 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Severe Renal Impairment	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
Total	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8

Limitations and caveats (from the sponsor): Since the study was terminated, the results of this study was not complete and the interpretation of the study results was limited.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37917289Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.
Derived from this study: PubMed 36977960Purohit V, Huh Y, Wojciechowski J, Plotka A, Salts S, Antinew J, Dimitrova A, Nicholas T. Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics. AAPS J. 2023 Mar 28;25(3):32. doi: 10.1208/s12248-023-00792-8.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center study director

Pfizer

3 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 PF-06651600 in people with Renal Impairment, run by Pfizer at 3 sites in United States.

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 8 inclusion and 10 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 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Plasma PF-06651600 Maximum Plasma Concentration (Cmax) (time frame: On Day 8 and Day 9 predose, and at 0 (predose), 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 hours after dose on Day 10, and 24 hours after dose on Day 11.). The study lists 2 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 NCT04037865, which also lists 2 linked publications.

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 18 May 2021.