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Completed

NCT Number: NCT05884554

A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, LLC, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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

Exclusion criteria

  • 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.

Treatment and study plan

PF-07817883

Drug

Experimental

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of PF-07817883

    Time frame: Day 1 to Day 6

    Plasma PF-07817883 PK parameters

  2. 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

  3. 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

Secondary outcomes

  1. Number of Participants with Non-Serious Adverse Events

    Time frame: Screening to Day 35

    Safety Parameters

  2. Number of Participants with Treatment Emergent Adverse Events

    Time frame: Day 1 to Day 35

    Safety Parameters

  3. Number of Participants with Clinically Significant ECG Abnormalities

    Time frame: Day 1 to Day 6

    ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate

  4. Number of Participants with Clinically Significant Abnormal Vital Signs

    Time frame: Day 1 to Day 6

    Vital Signs parameters include diastolic blood pressure, systolic blood pressure, and pulse rate

  5. Number of Participants with Clinically Significant Abnormal Laboratory Values

    Time frame: Baseline to Day 6

    Blood hematology and Chemistry and Urinalysis

  6. Number of Participants with Serious Adverse Events

    Time frame: Screening to Day 35

    Safety Parameters

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2023
Registry last updated
Sep 19, 2024

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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