Healthy VolunteerPhase 1NCT04260464

Renal Impairment Study of PF-06700841

A Phase 1 study testing PF-06700841 in people with Healthy Volunteer and Renal Impairment, run by Pfizer at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to characterize the effect of kidney impairment on the blood concentrations of PF-06700841 and its major metabolite. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of kidney… Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer, Renal Impairment
What is being tested?: PF-06700841
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 3 sitesUnited States
Study dates: 3 Jul 2020to 4 May 2022
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

Male or female participants who are between the ages of 18 and 75 years, inclusive, at the Screening visit.
Body mass index (BMI) of ≥17.5 to ≤40 kg/m2; and a total body weight >50 kg.
Normal, Severe, Moderate and Mild renal function at 2 Screening visits.
Stable drug regimen

Who cannot join

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 to first dose
Known history of pulmonary embolism or recurrent deep vein thrombosis
Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

Official title: A PHASE 1, NON-RANDOMIZED, OPEN LABEL, SINGLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-06700841 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-06700841 after a single oral dose of 30 mg. 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 4 will be a maximum of 32 days and from Screening visit to Follow-up/Contact Visit will a maximum of 67 days.

Conditions: Healthy Volunteer, Renal Impairment
Being tested: PF-06700841
Keywords: Pharmacokinetics
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-06700841Drug
A single dose of 30 mg PF-06700841 will be administered on Day 1

Study groups in NCT04260464
Study group	Role	What they receive
PF-06700841 Severe Renal Impairment	Experimental	This arm includes participants with severe renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1 Receives: Drug: PF-06700841
PF-06700841 Normal Renal Function	Experimental	This arm includes participants with normal renal function who will receive a single oral dose of 30 mg PF-06700841 on Day 1 Receives: Drug: PF-06700841
PF-06700841 Moderate Renal Impairment	Experimental	This arm includes participants with moderate renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1 Receives: Drug: PF-06700841
PF-06700841 Mild Renal Impairment	Experimental	This arm includes participants with mild renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1 Receives: Drug: PF-06700841

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
Cmax is the maximum observed plasma concentration of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06700841 from the concentration-time data.
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
Cmax is the maximum observed plasma concentration of PF-06802530 (M1), a major metabolite of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06802530 (M1), a major metabolite of PF-06700841 from the concentration-time data.
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

Secondary outcomes (4)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any events occurring following start of treatment or increasing in severity after the start of the treatment were counted as treatment emergent. An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect. Severe adverse events is an event that prevents normal everyday activities which is a category utilized for rating the intensity of an event.
Measured: From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
The hematology, clinical chemistry and urinalysis abnormalities were summarized in accordance with the sponsor reporting standards without regard to baseline abnormality. Baseline is defined as the last planned predose measurement taken on Day -1.
Measured: Baseline (Day -1) and Day 4
Number of Participants With Post-baseline Vital Sign Abnormalities
Vital Signs were assessed against the criteria specified in the sponsor reporting standards for potential clinical concerns. Vital sign abnormalities criteria included: 1) Systolic blood pressure (BP) in millimeters of mercury (mmHg): <90 mmHg with increase or decrease from baseline of ≥30 mmHg with high and low post baseline values; 2) Diastolic blood pressure (BP) (mmHg): <50 mmHg with increase or decrease from baseline of ≥20 mmHg with high and low post baseline values; 3) Supine pulse rate in beats per minutes (bpm): >120 or <40 bpm. Categories with at least 1 participant having vital sign abnormality in any of the reporting arms, were reported in this outcome measure. Baseline is defined as the last planned predose measurement taken on Day 1.
Measured: Baseline (Day 1) and Day 4
Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities
ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcB) in millisecond (msec): > 450, >480, >500, increase from baseline >30, increase from baseline >60; 2) QTc interval adjusted according to Fridericia formula (QTcF) (msec): >450, >480, >500, increase from baseline >30, increase from baseline >60. Categories with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure. Baseline is defined as the last planned predose measurement taken on Day 1.
Measured: 0 hr pre-dose and 1-, 3-, and 6-hours post-dose on Day 1; Day 4

Timeline

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

3 Jul 20204 May 2022

First posted7 Feb 2020
Study start3 Jul 2020
Primary completion4 May 2022
Study completion4 May 2022

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.
Other trials for Healthy VolunteerStudies 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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04260464
Sponsor's protocol ID: B7931048
Status last verified: Apr 2023
First submitted: 5 Feb 2020
Last updated: 22 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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.

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 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, NON-RANDOMIZED, OPEN LABEL, SINGLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-06700841 IN PARTICIPANTS WITH RENAL IMPAIRMENT AND IN HEALTHY PARTICIPANTS WITH NORMAL RENAL FUNCTION
ClinicalTrials.gov ID: NCT04260464
Acronym / sponsor ID: B7931048
Conditions: Healthy Volunteer, Renal Impairment
Keywords: Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 3 Jul 2020 (actual)
Primary completion: 4 May 2022 (actual)
Study completion: 4 May 2022 (actual)
First posted: 7 Feb 2020 (actual)
Results: Posted 22 Jan 2024

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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: Single group

Arm	Type	Receives
PF-06700841 Severe Renal Impairment	Experimental	Drug: PF-06700841This arm includes participants with severe renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1
PF-06700841 Normal Renal Function	Experimental	Drug: PF-06700841This arm includes participants with normal renal function who will receive a single oral dose of 30 mg PF-06700841 on Day 1
PF-06700841 Moderate Renal Impairment	Experimental	Drug: PF-06700841This arm includes participants with moderate renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1
PF-06700841 Mild Renal Impairment	Experimental	Drug: PF-06700841This arm includes participants with mild renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1

Who may qualify

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

Key inclusion criteria (4 listed)

Male or female participants who are between the ages of 18 and 75 years, inclusive, at the Screening visit.
Body mass index (BMI) of ≥17.5 to ≤40 kg/m2; and a total body weight >50 kg.
Normal, Severe, Moderate and Mild renal function at 2 Screening visits.
Stable drug regimen

Key exclusion criteria (5 listed)

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 to first dose
Known history of pulmonary embolism or recurrent deep vein thrombosis
Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).

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-06700841A single dose of 30 mg PF-06700841 will be administered on Day 1	Drug	PF-06700841 Mild Renal Impairment, PF-06700841 Moderate Renal Impairment, PF-06700841 Normal Renal Function, PF-06700841 Severe Renal Impairment

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Cmax is the maximum observed plasma concentration of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06700841 from the concentration-time data.
Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Cmax is the maximum observed plasma concentration of PF-06802530 (M1), a major metabolite of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.
AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06802530 (M1), a major metabolite of PF-06700841 from the concentration-time data.

4 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Time frame: Baseline (Day -1) and Day 4
Number of Participants With Post-baseline Vital Sign Abnormalities
Time frame: Baseline (Day 1) and Day 4
Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities
Time frame: 0 hr pre-dose and 1-, 3-, and 6-hours post-dose on Day 1; Day 4

Results and safety

Results posted to the registry on 22 Jan 2024, 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
Normal Renal Function	7	7
Moderate Renal Impairment	7	7
Mild Renal Impairment	8	8

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Severe Renal Impairment n = 8	Normal Renal Function n = 7	Moderate Renal Impairment n = 7	Mild Renal Impairment n = 8
Value	303.2 (34)	275.2 (27)	341.8 (17)	260.3 (89)

Severe Renal Impairment vs Normal Renal Function: Test/Reference Ratio: 110.15 (95% CI 83.76 to 144.86)
Normal Renal Function vs Mild Renal Impairment: Test/Reference Ratio: 94.58 (90% CI 55.84 to 160.19)
Normal Renal Function vs Moderate Renal Impairment: Test/Reference Ratio: 124.20 (90% CI 100.24 to 153.89)

Population analysed: The PK concentration population is defined as all participants assigned to investigational product and treated who have at least 1 concentration measured.

Primary outcome: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Severe Renal Impairment n = 8	Normal Renal Function n = 6	Moderate Renal Impairment n = 7	Mild Renal Impairment n = 8
Value	2013 (57)	1796 (77)	2652 (75)	1274 (199)

Severe Renal Impairment vs Normal Renal Function: Test/Reference Ratio: 112.08 (95% CI 60.85 to 206.45)
Normal Renal Function vs Mild Renal Impairment: Test/Reference Ratio: 70.97 (90% CI 27.60 to 182.49)
Normal Renal Function vs Moderate Renal Impairment: Test/Reference Ratio: 147.70 (90% CI 75.17 to 290.21)

Population analysed: The PK parameter analysis population is defined as all participants assigned to investigational product and treated who have at least 1 of the PK parameters of primary interest measured.

Primary outcome: Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Severe Renal Impairment n = 8	Normal Renal Function n = 7	Moderate Renal Impairment n = 7	Mild Renal Impairment n = 8
Value	250.4 (26)	141.0 (32)	172.1 (46)	187.1 (43)

Severe Renal Impairment vs Normal Renal Function: Test/Reference Ratio: 177.53 (95% CI 135.82 to 232.04)
Normal Renal Function vs Mild Renal Impairment: Test/Reference Ratio: 132.69 (90% CI 95.08 to 185.17)
Normal Renal Function vs Moderate Renal Impairment: Test/Reference Ratio: 122.04 (90% CI 84.47 to 176.30)

Population analysed: The PK concentration population is defined as all participants assigned to investigational product and treated who have at least 1 concentration measured.

Primary outcome: AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Severe Renal Impairment n = 7	Normal Renal Function n = 7	Moderate Renal Impairment n = 7	Mild Renal Impairment n = 8
Value	7756 (41)	1739 (24)	3984 (15)	2515 (32)

Severe Renal Impairment vs Normal Renal Function: Test/Reference Ratio: 445.99 (95% CI 326.55 to 609.13)
Normal Renal Function vs Mild Renal Impairment: Test/Reference Ratio: 144.63 (90% CI 112.76 to 185.50)
Normal Renal Function vs Moderate Renal Impairment: Test/Reference Ratio: 229.12 (90% CI 189.97 to 276.35)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 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%)	2 of 8 (25%)	0 of 8
Normal Renal Function	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Moderate Renal Impairment	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7
Mild Renal Impairment	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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-06700841 in people with Healthy Volunteer and 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 4 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: finished, as of the sponsor's last update on 22 Jan 2024. 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 22 Jan 2024). 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?

Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function (time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose). The study lists 4 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 NCT04260464.

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 22 Jan 2024.