A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: COVID-19

Treatments: Drug: PF-07817883

Study type: Interventional

Funder types: Industry

Identifiers

NCT06586216

C5091015

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 3 patient groups

Cohort 1

Experimental group

Description:

No renal impairment

Treatment:

Drug: PF-07817883

Cohort 2

Experimental group

Description:

Severe renal impairment

Treatment:

Drug: PF-07817883

Cohort 3

Experimental group

Description:

Moderate renal impairment

Treatment:

Drug: PF-07817883