PF-07817883
DrugExperimental
NCT Number: NCT05884554
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Anaheim Clinical Trials, LLC, Anaheim, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Experimental
Time frame: Day 1 to Day 6
Plasma PF-07817883 PK parameters
Time frame: Day 1 to Day 6
Plasma PF-07817883 PK parameter
Time frame: Day 1 to Day 6
(Optional) Plasma PF-07817883 parameter
Time frame: Screening to Day 35
Safety Parameters
Time frame: Day 1 to Day 35
Safety Parameters
Time frame: Day 1 to Day 6
ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate
Time frame: Day 1 to Day 6
Vital Signs parameters include diastolic blood pressure, systolic blood pressure, and pulse rate
Time frame: Baseline to Day 6
Blood hematology and Chemistry and Urinalysis
Time frame: Screening to Day 35
Safety Parameters
Pfizer
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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