Renal ImpairmentPhase 1NCT04909853

Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function.

A Phase 1 study testing PF-07321332/ritonavir in people with Renal Impairment, run by Pfizer at 5 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

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-07321332/ritonavir
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 5 sitesUnited States
Study dates: 15 Jun 2021to 7 Oct 2021
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, non-smoker and/or light smoker
Have a diagnosis of stable renal impairment
Meet the following estimated glomerular filtration rate (eGFR) criteria during the screening period (based on 2 Screening visits) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation:
Mild renal impairment: eGFR between 60 - 89 mL/min.
Moderate renal impairment: eGFR ≥30 mL/min and <60 mL/min.
Severe renal impairment: eGFR <30 mL/min, but not requiring hemodialysis.

Show all 16Show fewer

Normal renal function: eGFR ≥90 mL/min
Renal impairment participants:
Any form of renal impairment except acute nephritic syndrome (participants with history of previous nephritic syndrome but in remission can be included).
Good general health commensurate with the population with chronic kidney disease (renal impairment).
Stable concomitant drug regimen for the management of individual participant's medical conditions, so long as they are considered necessary for the welfare of the study participants (eg, standard therapy for underlying diseases), and are not contraindicated with study drug, and are unlikely to interfere with the PK of study drug.
Healthy participants with normal renal function:
No clinically relevant abnormalities identified by a detailed medical history, full physical examination, including temperature, blood pressure (BP) and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
Demographically comparable to the group of participants with impaired renal function.
Each participant's body weight within ±15 kg of the mean body weight of renal impairment group.
Each participant's age within ±10 years of the mean age of the renal impairment group.

Who cannot join

Positive test result for SARS-CoV-2 infection at the time of screening or Day -1.
History of HIV infection, hepatitis B, or hepatitis C; positive testing at screening for HIV, HBsAg, HBcAb, or HCVAb. As an exception a positive HBsAb test due to Hepatitis B vaccination is allowed.
Renal transplant recipients.
Urinary incontinence without catheterization
Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, cholecystectomy, appendectomy).
Participants who have been vaccinated with COVID-19 vaccines within the past 2 weeks of dosing, or are to be vaccinated with these vaccines at any time during the study.

Show all 17Show fewer

A positive urine drug test, for illicit drugs, at Screening
aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >2 × upper limit of normal (ULN)
Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is≤ ULN.
History of sensitivity reactions to ritonavir or any of the formulation components of PF 07321332 or ritonavir.
Female participants of childbearing potential who are unwilling or unable to use highly effective methods of contraception as outlined in Section 5.3.4 for the duration of the study and for at least 28 days after the administration of investigational product, pregnant female participants, female participants planning to become pregnant during the duration of the study until 28 days after the administration of investigational product, breastfeeding female participants.
Renal impairment participants:
Participants requiring hemodialysis and/or peritoneal dialysis
Participants with other clinically significant disease that may affect the safety of the participant or that may affect the PK of PF-07321332. Participants with any significant hepatic, cardiac, or pulmonary disease or participants who are clinically nephrotic.
Healthy participants with normal renal function:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Screening supine BP >140 mm Hg (systolic) or >90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is >140 mm Hg (systolic) or >90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 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 Research LLC dba Nucleus Network
Saint Paul, Minnesota, 55114
Genesis Clinical Research, LLC
Tampa, Florida, 33603
Orange County Research Center
Tustin, California, 92780

Other trials in United States

About this study

Official title: A PHASE 1, NON-RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07321332 BOOSTED WITH RITONAVIR IN ADULT PARTICIPANTS WITH RENAL IMPAIRMENT AND IN HEALTHY PARTICIPANTS WITH NORMAL RENAL FUNCTION.

This is a Phase 1, non-randomized, open-label, 2-part study to investigate the effect of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF-07321332 in combination with the PK boosting agent ritonavir. Participants will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: will be conducted in approximately 24 participants (approximately 8 per group) with stable mild or moderate renal impairment and a control group of participants with normal renal function. Part 2 will be conducted in approximately 8 participants with stable severe renal impairment.

Conditions: Renal Impairment
Being tested: PF-07321332/ritonavir
Keywords: SARS-CoV-2, COVID-19
Medical subject headings: Renal Insufficiency, COVID-19

What participants receive

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

PF-07321332/ritonavirDrug
Also called PF-07321332
PF-07321332 in combination with the PK boosting agent, ritonavir, being developed for the treatment of COVID-19

Study groups in NCT04909853
Study group	Role	What they receive
PF-07321332	Experimental	PF 07321332/ritonavir Receives: Drug: PF-07321332/ritonavir

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of PF-07321332
Measured: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1
Area Under the Plasma Concentration-time Profile From Time Zero (0) to Extrapolated Infinite Time (AUCinf) of PF-07321332
AUCinf was calculated by AUClast + (Clast/kel). AUClast was the area under the plasma concentration-time profile from time 0 to the time of Clast. Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Measured: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1
Amount of PF-07321332 Excreted Unchanged in Urine Over 48 Hours (Ae48)
Total amount of unchanged drug excreted in the urine over 48 hours.
Measured: Part 1 and Part 2: 0 to 48 hours post dose on Day 1
Renal Clearance (CLr) of PF-07321332
Renal clearance was calculated as total amount of unchanged drug excreted in the urine over 48 hours (Ae48) divided by area under the plasma concentration-time profile from time 0 to 48 hours post dose.
Measured: Part 1 and Part 2: 0 to 48 hours post dose on Day 1

Secondary outcomes (12)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that, at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent was considered serious; other important medical events. TEAEs were events occurred following start of treatment or increased in severity up to maximum of 35 days after last dose. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness was judged by investigator.
Measured: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)
Number of Participants With Clinical Laboratory Abnormalities
The hematology, clinical chemistry and urinalysis tests were included in the laboratory examination. The criteria for hematology evaluation included hemoglobin less than (<) 0.8*lower limit of normal (LLN), hematocrit <0.8*LLN, erythrocytes <0.8*LLN, erythrocyte mean corpuscular hemoglobin <0.9*LLN and lymphocytes <0.8*LLN. The criteria for clinical chemistry evaluation included neutrophils <0.8*LLN, eosinophils greater than (>) 1.2* upper limit of normal (ULN), monocytes >1.2*ULN, urea nitrogen >1.3*ULN, creatinine >1.3*ULN, urate >1.2*ULN, potassium >1.1*ULN and bicarbonate <0.9*LLN. The criteria for urinalysis evaluation included thyrotropin >1.2*ULN, glucose >1.5*ULN, fibrinogen >1.25*baseline, ketones greater than or equal to (>=) 1, urine protein >=1, nitrite >=1 and leukocyte esterase >=1.
Measured: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)
Number of Participants With Clinically Significant Vital Signs Abnormalities
Supine blood pressure, pulse rate, respiratory rate and oral temperature were evaluated in vital signs examination. Clinical significance was judged by investigator.
Measured: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)
Number of Participants With Clinically Significant Findings in Physical Examination
A complete physical examination included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. Clinical significance was judged by investigator.
Measured: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)
Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
A standard 12-lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position. Clinical significance was judged by investigator.
Measured: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)
Plasma Concentration of PF-07321332 at 12 Hours Post Dose (C12)
Measured: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1
Plasma Concentration of PF-07321332 at 24 Hours Post Dose (C24)
Measured: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332
Tmax was observed directly from data as time of first occurrence.
Measured: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1
Area Under the Plasma Concentration-time Profile From Time Zero (0) to the Time of the Last Quantifiable Concentration (AUClast) of PF-07321332
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration was determined by linear/log trapezoidal method.
Measured: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1
Apparent Clearance (CL/F) of PF-07321332 From Plasma
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma. CL/F was calculated by Dose/AUCinf.
Measured: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1
Apparent Volume of Distribution (Vz/F) of PF-07321332
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Vz/F was calculated by dose/(AUCinf*kel). kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Measured: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1
Terminal Elimination Plasma Half-life (t1/2) of PF-07321332
t1/2 was calculated by Loge(2)/kel. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Measured: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1

Timeline

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

15 Jun 20217 Oct 2021

First posted2 Jun 2021
Study start15 Jun 2021
Primary completion7 Oct 2021
Study completion7 Oct 2021

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 (1)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: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04909853
Sponsor's protocol ID: C4671011
Status last verified: Sep 2022
First submitted: 29 May 2021
Last updated: 2 Aug 2023
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.

Publications

Toussi SS, Neutel JM, Navarro J, Preston RA, Shi H, Kavetska O, LaBadie RR, Binks M, Chan PLS, Demers N, Corrigan B, Damle B. Pharmacokinetics of Oral Nirmatrelvir/Ritonavir, a Protease Inhibitor for Treatment of COVID-19, in Subjects With Renal Impairment. Clin Pharmacol Ther. 2022 Oct;112(4):892-900. doi: 10.1002/cpt.2688. Epub 2022 Jul 5.
PubMed 35712797

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

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, NON-RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07321332 BOOSTED WITH RITONAVIR IN ADULT PARTICIPANTS WITH RENAL IMPAIRMENT AND IN HEALTHY PARTICIPANTS WITH NORMAL RENAL FUNCTION.
ClinicalTrials.gov ID: NCT04909853
Acronym / sponsor ID: C4671011
Conditions: Renal Impairment
Keywords: SARS-CoV-2, COVID-19
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 15 Jun 2021 (actual)
Primary completion: 7 Oct 2021 (actual)
Study completion: 7 Oct 2021 (actual)
First posted: 2 Jun 2021 (actual)
Results: Posted 2 Aug 2023

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: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PF-07321332	Experimental	Drug: PF-07321332/ritonavirPF 07321332/ritonavir

Who may qualify

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

Key inclusion criteria (16 listed)

Male or female, non-smoker and/or light smoker
Have a diagnosis of stable renal impairment
Meet the following estimated glomerular filtration rate (eGFR) criteria during the screening period (based on 2 Screening visits) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation:
Any form of renal impairment except acute nephritic syndrome (participants with history of previous nephritic syndrome but in remission can be included).
Good general health commensurate with the population with chronic kidney disease (renal impairment).

Key exclusion criteria (17 listed)

Positive test result for SARS-CoV-2 infection at the time of screening or Day -1.
History of HIV infection, hepatitis B, or hepatitis C; positive testing at screening for HIV, HBsAg, HBcAb, or HCVAb. As an exception a positive HBsAb test due to Hepatitis B vaccination is allowed.
Renal transplant recipients.
Urinary incontinence without catheterization
Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, cholecystectomy, appendectomy).

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-07321332/ritonavirAlso: PF-07321332PF-07321332 in combination with the PK boosting agent, ritonavir, being developed for the treatment of COVID-19	Drug	PF-07321332

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of PF-07321332
Time frame: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1
Area Under the Plasma Concentration-time Profile From Time Zero (0) to Extrapolated Infinite Time (AUCinf) of PF-07321332
Time frame: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1
AUCinf was calculated by AUClast + (Clast/kel). AUClast was the area under the plasma concentration-time profile from time 0 to the time of Clast. Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Amount of PF-07321332 Excreted Unchanged in Urine Over 48 Hours (Ae48)
Time frame: Part 1 and Part 2: 0 to 48 hours post dose on Day 1
Total amount of unchanged drug excreted in the urine over 48 hours.
Renal Clearance (CLr) of PF-07321332
Time frame: Part 1 and Part 2: 0 to 48 hours post dose on Day 1
Renal clearance was calculated as total amount of unchanged drug excreted in the urine over 48 hours (Ae48) divided by area under the plasma concentration-time profile from time 0 to 48 hours post dose.

12 secondary outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs
Time frame: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)
Number of Participants With Clinically Significant Vital Signs Abnormalities
Time frame: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)
Number of Participants With Clinically Significant Findings in Physical Examination
Time frame: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)
Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
Time frame: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days)
Plasma Concentration of PF-07321332 at 12 Hours Post Dose (C12)
Time frame: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1
Plasma Concentration of PF-07321332 at 24 Hours Post Dose (C24)
Time frame: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332
Time frame: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1
Area Under the Plasma Concentration-time Profile From Time Zero (0) to the Time of the Last Quantifiable Concentration (AUClast) of PF-07321332
Time frame: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1
Apparent Clearance (CL/F) of PF-07321332 From Plasma
Time frame: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1
Apparent Volume of Distribution (Vz/F) of PF-07321332
Time frame: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1
Terminal Elimination Plasma Half-life (t1/2) of PF-07321332
Time frame: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1

Results and safety

Results posted to the registry on 2 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: Normal Renal Function	10	10
Part 1: Mild Renal Impairment	8	8
Part 1: Moderate Renal Impairment	9	8
Part 2: Severe Renal Impairment	0	0

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of PF-07321332

Time frame: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: Nanogram per milliliter

Measure	Part 1: Normal Renal Function n = 10	Part 1: Mild Renal Impairment n = 8	Part 1: Moderate Renal Impairment n = 8	Part 2: Severe Renal Impairment n = 8
Value	1600 (31)	2077 (29)	2210 (17)	2369 (38)

Part 1: Normal Renal Function vs Part 1: Mild Renal Impairment: Ratio of Adjusted Geometric Means: 129.78 (90% CI 101.93 to 165.25)
Part 1: Normal Renal Function vs Part 1: Moderate Renal Impairment: Ratio of Adjusted Geometric Means: 138.12 (90% CI 113.18 to 168.55)
Part 1: Normal Renal Function vs Part 2: Severe Renal Impairment: Ratio of Adjusted Geometric Means: 148.02 (90% CI 111.40 to 196.68)

Population analysed: The pharmacokinetic (PK) parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest

Primary outcome: Area Under the Plasma Concentration-time Profile From Time Zero (0) to Extrapolated Infinite Time (AUCinf) of PF-07321332

Time frame: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: Nanogram*hour per milliliter

Measure	Part 1: Normal Renal Function n = 10	Part 1: Mild Renal Impairment n = 8	Part 1: Moderate Renal Impairment n = 6	Part 2: Severe Renal Impairment n = 7
Value	14460 (20)	17910 (30)	27110 (27)	44040 (33)

Part 1: Normal Renal Function vs Part 1: Mild Renal Impairment: Ratio of Adjusted Geometric Means: 123.84 (90% CI 99.64 to 153.91)
Part 1: Normal Renal Function vs Part 1: Moderate Renal Impairment: Ratio of Adjusted Geometric Means: 187.40 (90% CI 148.52 to 236.46)
Part 1: Normal Renal Function vs Part 2: Severe Renal Impairment: Ratio of Adjusted Geometric Means: 304.49 (90% CI 237.60 to 390.21)

Population analysed: The PK parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.

Primary outcome: Amount of PF-07321332 Excreted Unchanged in Urine Over 48 Hours (Ae48)

Time frame: Part 1 and Part 2: 0 to 48 hours post dose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: Milligram

Measure	Part 1: Normal Renal Function n = 10	Part 1: Mild Renal Impairment n = 8	Part 1: Moderate Renal Impairment n = 8	Part 2: Severe Renal Impairment n = 8
Value	31.20 (45)	42.65 (23)	30.83 (56)	18.46 (50)

Population analysed: The PK parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.

Primary outcome: Renal Clearance (CLr) of PF-07321332

Time frame: Part 1 and Part 2: 0 to 48 hours post dose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: Liters per hour

Measure	Part 1: Normal Renal Function n = 10	Part 1: Mild Renal Impairment n = 8	Part 1: Moderate Renal Impairment n = 8	Part 2: Severe Renal Impairment n = 8
Value	2.180 (50)	2.395 (33)	1.154 (71)	0.4398 (73)

Population analysed: The PK parameter analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Normal Renal Function	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Part 1: Mild Renal Impairment	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Part 1: Moderate Renal Impairment	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Part 2: Severe Renal Impairment	1 of 8 (12.5%)	5 of 8 (62.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35712797Toussi SS, Neutel JM, Navarro J, Preston RA, Shi H, Kavetska O, LaBadie RR, Binks M, Chan PLS, Demers N, Corrigan B, Damle B. Pharmacokinetics of Oral Nirmatrelvir/Ritonavir, a Protease Inhibitor for Treatment of COVID-19, in Subjects With Renal Impairment. Clin Pharmacol Ther. 2022 Oct;112(4):892-900. doi: 10.1002/cpt.2688. Epub 2022 Jul 5.
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.

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

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

5 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-07321332/ritonavir in people with Renal Impairment, run by Pfizer at 5 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 16 inclusion and 17 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 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 2 Aug 2023). 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-07321332 (time frame: Part 1 and Part 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose on Day 1). 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 NCT04909853, which also lists 1 linked publication.

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 2 Aug 2023.