A Phase 1 interventional study of PF-07817883 in COVID-19, sponsored by Pfizer. Completed at 6 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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:
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 21 is below the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No hepatic impairment
Drug: PF-07817883
Mild hepatic impairment
Drug: PF-07817883
Moderate hepatic impairment
Drug: PF-07817883
Severe hepatic impairment
Drug: PF-07817883
Experimental
Maximum Observed Plasma Concentration (Cmax) of PF-07817883
Plasma PF-07817883 PK parameters
Time frame: 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
Time frame: 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
Time frame: Day 1 to Day 6
Number of Participants with Non-Serious Adverse Events
Safety Parameters
Time frame: Screening to Day 35
Number of Participants with Treatment Emergent Adverse Events
Safety Parameters
Time frame: 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
Time frame: 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
Time frame: Day 1 to Day 6
Number of Participants with Clinically Significant Abnormal Laboratory Values
Blood hematology and Chemistry and Urinalysis
Time frame: Baseline to Day 6
Number of Participants with Serious Adverse Events
Safety Parameters
Time frame: Screening to Day 35
Plan to share: 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.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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