Clinical trial NCT06586216: A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: Renal Impairment
COVID-19
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of PF-07817883
timeFrame: Day 1 to Day 5
measure: Area under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)
timeFrame: Day 1 to Day 5
measure: Area under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
timeFrame: Day 1 to Day 5
Secondary outcomes:
measure: Number of participants with Non-Serious Adverse Events (NSAE)
timeFrame: Screening to Day 35
measure: Number of participants with Treatment Emergent Adverse Events
timeFrame: Day 1 to Day 35
measure: Number of participants with Clinically Significant ECG Abnormalities
timeFrame: Day 1 to Day 5
measure: Number of participants with Clinically Significant Abnormal Vital Signs
timeFrame: Day 1 to Day 5
measure: Number of participants with Clinically Significant abnormal laboratory values.
timeFrame: Baseline to Day 5
measure: Number of participants with Serious Adverse Events
timeFrame: Screening to Day 35
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC
state: Florida
city: Saint Paul
country: United States
facility: Prism Research LLC dba Nucleus Network
state: Minnesota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: