CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
PF-07081532drug
Likely dose
PF-07081532 20 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05478603
NCT05478603Phase 1Completed

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF PF-07081532 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT

Pfizer·interventional·Posted Jul 28, 2022·Updated Aug 22, 2024

In Brief

A Phase 1 clinical trial evaluating PF-07081532 for Hepatic Impairment and Healthy Volunteers. Completed, enrolled 24 participants across 2 sites.

Detailed Summary

The purpose of this study is to understand the effects of liver functional impairment on the study medicine (PF-07081532). People with liver functional impairment may process the study medicine differently from healthy people. We are seeking participants who: * Are between 18 and 70 years of age; * Have a BMI (body mass index) of 17.5 to 38.0 kg/m2, inclusive, and a total body weight \>50 kg (110 lbs.). Participants will take the study medicine as a tablet once at the study clinic, and then will stay onsite for about 7 days. During this time, the study team will monitor their treatment experience and take some blood samples to test the level of PF-07081532. This will help us understand if certain level of liver functional impairment could affect the study medicine being processed in the body.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJul 28, 2022
Enrollment StartAug 1, 2022
Primary CompletionApr 5, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.9 years ago

Interventions

PF-07081532drug

PF-07081532 20 milligrams (mg), 1 tablet orally, once on Day 1