A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.
Public ClinicalTrials.gov record NCT05884554. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05884554
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 14, 2023
- Primary completion
- Jun 26, 2024
- Completion
- Jun 26, 2024
- Last update posted
- Sep 18, 2024
2023 – 2024
United States locations
- U.S. sites
- 6
- U.S. states
- 2
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | — |
| National Institute of Clinical Research | Garden Grove | California | 92844 | — |
| Catalina Research Institute, LLC | Montclair | California | 91763 | — |
| Research Centers of America ( Hollywood ) | Hollywood | Florida | 33024 | — |
| Research Centers of America | Hollywood | Florida | 33024 | — |
| Genesis Clinical Research, LLC | Tampa | Florida | 33603 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05884554, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05884554 live on ClinicalTrials.gov.