COVID-19Phase 1NCT05884554
A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.
A Phase 1 study testing PF-07817883 in people with COVID-19, run by Pfizer at 6 sites in United States.
Trial summary
The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 21 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Jun 2023to 27 Jun 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (HI Cohorts Only): Stable HI that meets criteria for Class A or B of the Child-Pugh classification;
- (all Cohorts): BMI of 17.5 to 38.0 kg/m2
Who cannot join
- Any condition possibly affecting drug absorption Additional Exclusion Criteria for HI Cohorts Only
- Limited predicted life expectancy
- Hepatic dysfunction secondary to acute ongoing hepatocellular process.
- Signs of clinically active Grade 2, 3 or 4 hepatic encephalopathy.
- Severe ascites and/or pleural effusion
- History of kidney, liver, or heart transplantation.
- Persistent severe, uncontrolled hypertension.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
National Institute of Clinical Research
Garden Grove, California, 92844
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024
Research Centers of America
Hollywood, Florida, 33024
Catalina Research Institute, LLC
Montclair, California, 91763
Genesis Clinical Research, LLC
Tampa, Florida, 33603
About this study
Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO ASSESS PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07817883 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups.
This study is seeking participants who:
Read more
- are male or female of 18- 75 years of age
- either have different amounts of damage to liver function or for one of the groups, no damage
- willing to follow the requirements of the study including stay at clinic for 6 nights and 7 days
About, 6-8 participants will be enrolled in group 1 (participants without loss of liver function) and group 3 (participants with moderate loss of liver function). In group 4 (participants with severe loss of function), around 4 to 8 participants will be enrolled. Participants in group 2 (mild loss of function) will only be enrolled after review of the data from groups 3 and 4.
If participants consent to participate in the study, it may take up to 4 weeks to complete all the tests to confirm if they are eligible to participate in the study. If they seem to be eligible for the study, participants will be admitted to a clinic research unit (CRU) at least 12 hours before dosing. On Day 1, participants will receive a single dose of study medicine (Day 1). A series of blood samples will be collected before and after dosing. Participants will be discharged from the CRU on Day 6. A follow-up phone call (on CRU visit, if needed), will occur 28-35 days after dosing.
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
- Hepatic Impairment, COVID-19
- Medical subject headings
- COVID-19
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 hepatic impairment Receives: Drug: PF-07817883 |
| Cohort 2 | Experimental | Mild hepatic impairment Receives: Drug: PF-07817883 |
| Cohort 3 | Experimental | Moderate hepatic impairment Receives: Drug: PF-07817883 |
| Cohort 4 | Experimental | Severe hepatic 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 6
Area Under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)
Plasma PF-07817883 PK parameter
Measured: Day 1 to Day 6
Area Under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
(Optional) Plasma PF-07817883 parameter
Measured: Day 1 to Day 6
Secondary outcomes (6)
Number of Participants with Non-Serious Adverse Events
Safety Parameters
Measured: Screening to Day 35
Number of Participants with Treatment Emergent Adverse Events
Safety Parameters
Measured: Day 1 to Day 35
Number of Participants with Clinically Significant ECG Abnormalities
ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate
Measured: Day 1 to Day 6
Number of Participants with Clinically Significant Abnormal Vital Signs
Vital Signs parameters include diastolic blood pressure, systolic blood pressure, and pulse rate
Measured: Day 1 to Day 6
Number of Participants with Clinically Significant Abnormal Laboratory Values
Blood hematology and Chemistry and Urinalysis
Measured: Baseline to Day 6
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 posted1 Jun 2023
- Study start15 Jun 2023
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
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
- 21 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
- NCT05884554
- Sponsor's protocol ID
- C5091014
- Status last verified
- Sep 2024
- First submitted
- 23 May 2023
- Last updated
- 19 Sep 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 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO ASSESS PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07817883 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
- ClinicalTrials.gov ID
- NCT05884554
- Acronym / sponsor ID
- C5091014
- Conditions
- COVID-19
- Keywords
- Hepatic Impairment, COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 1 Jun 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 the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups.
This study is seeking participants who:
- are male or female of 18- 75 years of age
- either have different amounts of damage to liver function or for one of the groups, no damage
- willing to follow the requirements of the study including stay at clinic for 6 nights and 7 days
About, 6-8 participants will be enrolled in group 1 (participants without loss of liver function) and group 3 (participants with moderate loss of liver function). In group 4 (participants with severe loss of function), around 4 to 8 participants will be enrolled. Participants in group 2 (mild loss of function) will only be enrolled after review of the data from groups 3 and 4.
If participants consent to participate in the study, it may take up to 4 weeks to complete all the tests to confirm if they are eligible to participate in the study. If they seem to be eligible for the study, participants will be admitted to a clinic research unit (CRU) at least 12 hours before dosing. On Day 1, participants will receive a single dose of study medicine (Day 1). A series of blood samples will be collected before and after dosing. Participants will be discharged from the CRU on Day 6. A follow-up phone call (on CRU visit, if needed), will occur 28-35 days after dosing.
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
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PF-07817883No hepatic impairment |
| Cohort 2 | Experimental | Drug: PF-07817883Mild hepatic impairment |
| Cohort 3 | Experimental | Drug: PF-07817883Moderate hepatic impairment |
| Cohort 4 | Experimental | Drug: PF-07817883Severe hepatic impairment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (HI Cohorts Only): Stable HI that meets criteria for Class A or B of the Child-Pugh classification;
- (all Cohorts): BMI of 17.5 to 38.0 kg/m2
Key exclusion criteria (7 listed)
- Any condition possibly affecting drug absorption Additional Exclusion Criteria for HI Cohorts Only
- Limited predicted life expectancy
- Hepatic dysfunction secondary to acute ongoing hepatocellular process.
- Signs of clinically active Grade 2, 3 or 4 hepatic encephalopathy.
- Severe ascites and/or pleural effusion
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, Cohort 4 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of PF-07817883
Time frame: Day 1 to Day 6
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 6
Plasma PF-07817883 PK parameter
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 6
(Optional) Plasma PF-07817883 parameter
6 secondary outcomes
Number of Participants with Non-Serious Adverse Events
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 6
Number of Participants with Clinically Significant Abnormal Vital Signs
Time frame: Day 1 to Day 6
Number of Participants with Clinically Significant Abnormal Laboratory Values
Time frame: Baseline to Day 6
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 Sep 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 PF-07817883 in people with COVID-19, 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 2 inclusion and 7 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 Sep 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) of PF-07817883 (time frame: Day 1 to Day 6). 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 Sep 2024.