Renal ImpairmentPhase 1NCT06037031
A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function
A Phase 1 study testing Drug: PF-07923568 in people with Renal Impairment, run by Pfizer at 6 sites in United States.
Trial summary
The purpose of this study is to understand how the loss of kidney function affects study medicine (PF-07923568) in the body. People with some level of loss of kidney function may process PF-07923568 differently from healthy people. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Drug: PF-07923568
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Oct 2023to 3 Jul 2024
- 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
- Stable renal function defined as ≤25% difference between 2 measurements of absolute estimated glomerular filtration rate (eGFR) during screening.
- Meet the eGFR criteria for cohort placement during the screening period.
- Body mass index (BMI) of 16-40 kg/m2; and a total body weight >45 kg (99 lb.).
- For Cohort 2 Normal Renal Function Group Only: At screening, meet the demographic-matching criteria, including body weight within ±15 kg and age within ±10 years, of the average of the pooled renal impairment cohort.
Who cannot join
- Participants with acute renal disease.
- Participants who are clinically nephrotic.
- Participants requiring hemodialysis.
- Renal allograft recipients.
- Participants who have previously received a kidney, liver, or heart transplant.
- Urinary incontinence without catheterization.
Show all 9Show fewer
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Orlando Clinical Research Center
Orlando, Florida, 32809
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, 55114
Clinical Trials of Texas, LLC
San Antonio, Texas, 78212
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, 78229
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
Genesis Clinical Research, LLC
Tampa, Florida, 33603
About this study
Official title: A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, SINGLE-DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07923568 IN ADULT PARTICIPANTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION
The purpose of this study is to understand how the loss of kidney function affects study medicine (PF-07923568) in the body. People with some level of loss of kidney function may process PF-07923568 differently from healthy people. PF-07923568 is developed as a possible treatment for respiratory syncytial virus (RSV) infection. RSV is a common virus that affects the lungs and usually causes mild, cold-like symptoms. RSV can cause severe lung infections in infants, elderly, and adults with other serious medical conditions.
This study is seeking participants who:
Read more
- Have less than 25% difference in kidney function between 2 screening visits.
- Meet the eGFR criteria for being assigned to groups. eGFR tells how well the kidney is filtering.
- Are not on hemodialysis. Hemodialysis is a type of treatment that helps the body remove extra fluid and waste products from the blood when the kidneys are not able to.
Participants will take the study medicine as capsules by mouth once at the study clinic. The participants will stay at the study clinic for about 5 days. During that time, the study team will monitor the participants. The study team will take some blood samples to test the level of PF-07923568. This will help us understand if some level of loss of kidney function will have an effect on the study medicine PF-07923568.
- Conditions
- Renal Impairment
- Being tested
- Drug: PF-07923568
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: PF-07923568Drug
Also called Sisunatovir
A single dose of PF-07923568 administered orally as 4 capsules
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Severe Renal Impairment | Experimental | Participants with severe renal impairment will receive a single oral dose of PF-07923568 Receives: Drug: Drug: PF-07923568 |
| Cohort 2: Normal Renal Function | Experimental | Participants with normal renal function will receive a single oral dose of PF-07923568 Receives: Drug: Drug: PF-07923568 |
| Cohort 3 (Optional): Moderate Renal Impairment | Experimental | Participants with moderate renal impairment will receive a single oral dose of PF-07923568 Receives: Drug: Drug: PF-07923568 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: Baseline through Day 5
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Measured: Baseline through Day 5
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: Baseline through Day 5
Secondary outcomes (4)
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Measured: Baseline through Day 36
Number of Participants With Change From Baseline in Laboratory Tests Results
Measured: Baseline through Day 5
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Measured: Baseline through Day 5
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)
Measured: Baseline through Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start30 Oct 2023
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 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
- NCT06037031
- Sponsor's protocol ID
- C5241016
- Status last verified
- Jul 2024
- First submitted
- 7 Sep 2023
- Last updated
- 19 Jul 2024
- 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 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, SINGLE-DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07923568 IN ADULT PARTICIPANTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION
- ClinicalTrials.gov ID
- NCT06037031
- Acronym / sponsor ID
- C5241016
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 14 Sep 2023 (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 this study is to understand how the loss of kidney function affects study medicine (PF-07923568) in the body. People with some level of loss of kidney function may process PF-07923568 differently from healthy people. PF-07923568 is developed as a possible treatment for respiratory syncytial virus (RSV) infection. RSV is a common virus that affects the lungs and usually causes mild, cold-like symptoms. RSV can cause severe lung infections in infants, elderly, and adults with other serious medical conditions.
This study is seeking participants who:
- Have less than 25% difference in kidney function between 2 screening visits.
- Meet the eGFR criteria for being assigned to groups. eGFR tells how well the kidney is filtering.
- Are not on hemodialysis. Hemodialysis is a type of treatment that helps the body remove extra fluid and waste products from the blood when the kidneys are not able to.
Participants will take the study medicine as capsules by mouth once at the study clinic. The participants will stay at the study clinic for about 5 days. During that time, the study team will monitor the participants. The study team will take some blood samples to test the level of PF-07923568. This will help us understand if some level of loss of kidney function will have an effect on the study medicine PF-07923568.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Severe Renal Impairment | Experimental | Drug: Drug: PF-07923568Participants with severe renal impairment will receive a single oral dose of PF-07923568 |
| Cohort 2: Normal Renal Function | Experimental | Drug: Drug: PF-07923568Participants with normal renal function will receive a single oral dose of PF-07923568 |
| Cohort 3 (Optional): Moderate Renal Impairment | Experimental | Drug: Drug: PF-07923568Participants with moderate renal impairment will receive a single oral dose of PF-07923568 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable renal function defined as ≤25% difference between 2 measurements of absolute estimated glomerular filtration rate (eGFR) during screening.
- Meet the eGFR criteria for cohort placement during the screening period.
- Body mass index (BMI) of 16-40 kg/m2; and a total body weight >45 kg (99 lb.).
- For Cohort 2 Normal Renal Function Group Only: At screening, meet the demographic-matching criteria, including body weight within ±15 kg and age within ±10 years, of the average of the pooled renal impairment cohort.
Key exclusion criteria (9 listed)
- Participants with acute renal disease.
- Participants who are clinically nephrotic.
- Participants requiring hemodialysis.
- Renal allograft recipients.
- Participants who have previously received a kidney, liver, or heart transplant.
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 |
|---|---|---|
| Drug: PF-07923568Also: SisunatovirA single dose of PF-07923568 administered orally as 4 capsules | Drug | Cohort 1: Severe Renal Impairment, Cohort 2: Normal Renal Function, Cohort 3 (Optional): Moderate Renal Impairment |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Baseline through Day 5
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Time frame: Baseline through Day 5
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: Baseline through Day 5
4 secondary outcomes
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Baseline through Day 36
Number of Participants With Change From Baseline in Laboratory Tests Results
Time frame: Baseline through Day 5
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline through Day 5
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)
Time frame: Baseline through Day 5
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 Jul 2024.
- 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
6 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 Drug: PF-07923568 in people with Renal Impairment, run by Pfizer at 6 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 9 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 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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) (time frame: Baseline through 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 Jul 2024.