COVID-19Phase 1NCT06586216
A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.
A Phase 1 study testing PF-07817883 in people with COVID-19, run by Pfizer at 3 sites in United States.
Trial summary
The purpose of the study is to learn about: how PF-07817883 is processed in the body of adult participants. the safety of PF-07817883. These participants will have different levels of kidney function loss: moderate severe none or healthy Participants with moderate, severe or no loss of kidney function may be taken… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- PF-07817883
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Sep 2024to 13 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 (or the minimum age of consent in accordance with local regulations) to 90 years of age at screening.
- BMI of ≥16 kg/m2 and a total body weight >45 kg (99 lbs).
- Stable renal function, defined as the eGFR values obtained at the two screening visits should not be more than 25% different.
Who cannot join
- Positive test result for severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) infection at the time of screening or Day -1.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HBsAb) test due to hepatitis B vaccination is allowed.
- Renal transplant recipients.
- Any condition possibly affecting drug absorption
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Pharmacology of Miami
Miami, Florida, 33014
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, 55114
Genesis Clinical Research, LLC
Tampa, Florida, 33603
About this study
Official title: A PHASE 1, NON-RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07817883 IN ADULT PARTICIPANTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION
The purpose of the study is to learn about:
- how PF-07817883 is processed in the body of adult participants.
- the safety of PF-07817883.
Read more
These participants will have different levels of kidney function loss:
- moderate
- severe
- none or healthy Participants with moderate, severe or no loss of kidney function may be taken into one of 3 groups.
This study is seeking for participants who:
- are male or female of 18 to 90 years of age.
- have different levels of damage to kidney function or for one of the groups, no damage
- are willing to follow the requirements of the study including stay at clinic for 5 nights and 6 days.
About, 8 participants may be selected in groups 2 and 3. In group 1, around 8 to 12 participants may be selected. If participants agree to take part in the study, it may take up to 4 weeks to complete all the tests to confirm if they are fit to be in the study. If they seem to be fit for the study, participants will be admitted to a clinic research unit (CRU) at least 8 hours before dosing.
On Day 1, participants will receive a single amount of study medicine (Day 1). A series of blood samples will be collected before and after giving medicines. Participants will be discharged from the CRU on Day 5. A follow-up phone call (or CRU visit, if needed), will occur 28-35 days after taking the medicine. The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.
- Conditions
- COVID-19
- Being tested
- PF-07817883
- Keywords
- Renal Impairment, COVID-19
- Medical subject headings
- COVID-19, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07817883Drug
Experimental
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | No renal impairment Receives: Drug: PF-07817883 |
| Cohort 2 | Experimental | Severe renal impairment Receives: Drug: PF-07817883 |
| Cohort 3 | Experimental | Moderate renal impairment Receives: Drug: PF-07817883 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of PF-07817883
Plasma PF-07817883 PK parameters
Measured: Day 1 to Day 5
Area under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)
Plasma PF-07817883 PK parameters
Measured: Day 1 to Day 5
Area under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
Plasma PF-07817883 parameters
Measured: Day 1 to Day 5
Secondary outcomes (6)
Number of participants with Non-Serious Adverse Events (NSAE)
Safety Parameter
Measured: Screening to Day 35
Number of participants with Treatment Emergent Adverse Events
Safety Parameter
Measured: Day 1 to Day 35
Number of participants with Clinically Significant ECG Abnormalities
Measured: Day 1 to Day 5
Number of participants with Clinically Significant Abnormal Vital Signs
Measured: Day 1 to Day 5
Number of participants with Clinically Significant abnormal laboratory values.
Measured: Baseline to Day 5
Number of participants with Serious Adverse Events
Safety parameters
Measured: Screening to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2024
- Primary completion13 Feb 2025
- Study completion13 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586216
- Sponsor's protocol ID
- C5091015
- Status last verified
- Feb 2025
- First submitted
- 1 Aug 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. 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-07817883 IN ADULT PARTICIPANTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION
- ClinicalTrials.gov ID
- NCT06586216
- Acronym / sponsor ID
- C5091015
- Conditions
- COVID-19
- Keywords
- Renal Impairment, COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to learn about:
- how PF-07817883 is processed in the body of adult participants.
- the safety of PF-07817883.
These participants will have different levels of kidney function loss:
- moderate
- severe
- none or healthy Participants with moderate, severe or no loss of kidney function may be taken into one of 3 groups.
This study is seeking for participants who:
- are male or female of 18 to 90 years of age.
- have different levels of damage to kidney function or for one of the groups, no damage
- are willing to follow the requirements of the study including stay at clinic for 5 nights and 6 days.
About, 8 participants may be selected in groups 2 and 3. In group 1, around 8 to 12 participants may be selected. If participants agree to take part in the study, it may take up to 4 weeks to complete all the tests to confirm if they are fit to be in the study. If they seem to be fit for the study, participants will be admitted to a clinic research unit (CRU) at least 8 hours before dosing.
On Day 1, participants will receive a single amount of study medicine (Day 1). A series of blood samples will be collected before and after giving medicines. Participants will be discharged from the CRU on Day 5. A follow-up phone call (or CRU visit, if needed), will occur 28-35 days after taking the medicine. The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PF-07817883No renal impairment |
| Cohort 2 | Experimental | Drug: PF-07817883Severe renal impairment |
| Cohort 3 | Experimental | Drug: PF-07817883Moderate renal impairment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female participants aged 18 (or the minimum age of consent in accordance with local regulations) to 90 years of age at screening.
- BMI of ≥16 kg/m2 and a total body weight >45 kg (99 lbs).
- Stable renal function, defined as the eGFR values obtained at the two screening visits should not be more than 25% different.
Key exclusion criteria (4 listed)
- Positive test result for severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) infection at the time of screening or Day -1.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HBsAb) test due to hepatitis B vaccination is allowed.
- Renal transplant recipients.
- Any condition possibly affecting drug absorption
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-07817883Experimental | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of PF-07817883
Time frame: Day 1 to Day 5
Plasma PF-07817883 PK parameters
Area under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)
Time frame: Day 1 to Day 5
Plasma PF-07817883 PK parameters
Area under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
Time frame: Day 1 to Day 5
Plasma PF-07817883 parameters
6 secondary outcomes
Number of participants with Non-Serious Adverse Events (NSAE)
Time frame: Screening to Day 35
Number of participants with Treatment Emergent Adverse Events
Time frame: Day 1 to Day 35
Number of participants with Clinically Significant ECG Abnormalities
Time frame: Day 1 to Day 5
Number of participants with Clinically Significant Abnormal Vital Signs
Time frame: Day 1 to Day 5
Number of participants with Clinically Significant abnormal laboratory values.
Time frame: Baseline to Day 5
Number of participants with Serious Adverse Events
Time frame: Screening to Day 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- 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-07817883 in people with COVID-19, 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 3 inclusion and 4 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 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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-07817883 (time frame: Day 1 to Day 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2025; AzTrials last refreshed its copy on 3 Nov 2026.