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

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ClinicalTrials.gov Identifier: NCT04909853
Recruitment Status : Recruiting
First Posted : June 2, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: PF-07321332/ritonavir Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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.
Actual Study Start Date : June 15, 2021
Estimated Primary Completion Date : October 14, 2021
Estimated Study Completion Date : October 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
Drug Information available for: Ritonavir

Arm Intervention/treatment
Experimental: PF-07321332
PF 07321332/ritonavir
Drug: PF-07321332/ritonavir
PF-07321332 in combination with the PK boosting agent, ritonavir, being developed for the treatment of COVID-19
Other Name: PF-07321332




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) for PF-07321332. [ Time Frame: 0 (predose) up to 48 hours post-dose ]
    Maximum observed plasma PF-07321332 concentration.

  2. Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-07321332 [ Time Frame: 0 (pre-dose) up to 48 hours post-dose ]
    Area under the plasma PF-07321332 concentration-time profile from time 0 extrapolated to infinite time.

  3. Amount of PF-07321332 excreted in urine unchanged [ Time Frame: up to 48 hours post-dose ]
    Total amount of unchanged drug excreted in the urine over 48 hours


Secondary Outcome Measures :
  1. Time to maximum concentration (Tmax) of PF-07321332 [ Time Frame: 0 (predose) up to 48 hours post-dose ]
  2. Area Under the Plasma Concentration-time Profile from Time 0 to Last Measurable PF-07321332 Concentration (AUClast) [ Time Frame: 0 (predose) up to 48 hours post-dose ]
  3. Number of Participants reporting Treatment-Emergent Adverse Events [ Time Frame: 1 to 35 days ]
  4. Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: 1 to 35 days ]
  5. Number of Participants With Vital Signs Abnormalities [ Time Frame: 1 to 35 days ]
  6. Number of Participants With Abnormalities in Physical Examination [ Time Frame: 1 to 35 days ]
  7. Number of Participants With Abnormal Electrocardiogram (ECG) [ Time Frame: 1 to 35 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
    • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04909853


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
Orange County Research Center Recruiting
Tustin, California, United States, 92780
United States, Florida
Genesis Clinical Research Not yet recruiting
Tampa, Florida, United States, 33603
United States, Minnesota
Prism Research LLC dba Nucleus Network Not yet recruiting
Saint Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04909853    
Other Study ID Numbers: C4671011
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
SARS-CoV-2
COVID-19
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Ritonavir
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors