---
title: Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
nct_id: NCT04091061
overall_status: COMPLETED
phase: PHASE1
sponsor: Pfizer
study_type: INTERVENTIONAL
primary_condition: Hepatic Impairment
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04091061.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04091061"
ct_last_update_post_date: 2021-04-13
last_seen_at: "2026-05-12T07:03:08.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects

**Official Title:** A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF 06865571 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT

**NCT ID:** [NCT04091061](https://clinicaltrials.gov/study/NCT04091061)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Pfizer
- **Conditions:** Hepatic Impairment, Healthy Volunteers
- **Start Date:** 2019-10-03
- **Completion Date:** 2020-04-07
- **CT.gov Last Update:** 2021-04-13

## Brief Summary

The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* Body mass index (BMI) of 17.5 to 35.4 kg/m2, inclusive; and a total body weight \>50 kg (110 lb), at the Screening visit; with a single repeat assessment of total body weight (and hence BMI), on a separate day permitted to assess eligibility, if needed.
* Capable of giving signed informed consent.

Exclusion Criteria

* Any condition possibly affecting drug absorption (eg, prior bariatric surgery,gastrectomy, ileal resection).
* At Screening, participants with a positive result for human immunodeficiency virus (HIV) antibodies, as assessed by sponsor-identified central laboratory, with a single repeat permitted to assess eligibility, if needed.
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer).
* Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF-06865571.
* A positive urine drug test, for illicit drugs on Day -1,
* At Screening or Day -1, a positive breath alcohol test.
* Male participants with partners who are currently pregnant.
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing and until the follow-up contact.
* Unwilling or unable to comply with the criteria in the Lifestyle Considerations.
* Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
```

## Arms

- **PF-06865571 Moderate Hepatic Impairment** (EXPERIMENTAL) — This arm includes participants with moderate hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1
- **PF-06865571 Severe Hepatic Impairment** (EXPERIMENTAL) — This arm includes participants with severe hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1
- **PF-06865571 Mild Hepatic Impairment** (EXPERIMENTAL) — This arm includes participants with mild hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1
- **PF-06865571 Healthy Participants** (EXPERIMENTAL) — This arm includes healthy participants who will receive an oral dose of PF-06865571 100 mg on Day 1

## Interventions

- **PF-06865571 100 mg** (DRUG) — PF-06865571 in 100 mg oral tablet will be administered on Day 1

## Primary Outcomes

- **Maximum Observed Plasma Concentration (Cmax)** _(time frame: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.)_ — Cmax of PF-06865571 was observed directly from data.
- **Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast)** _(time frame: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.)_ — AUClast of PF-06865571 was determined by linear/log trapezoidal method.
- **Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf)** _(time frame: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.)_ — AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf).

## Secondary Outcomes

- **Number of Participants With Treatment-Emergent Adverse Events (TEAEs)** _(time frame: Up to Day 32 (31 days after investigational product administration))_
- **Number of Participants With Clinical Laboratory Abnormalities** _(time frame: Up to Day 4 (3 days after investigational product administration))_
- **Number of Participants With Categorical Vital Signs Data** _(time frame: Up to Day 4 (3 days after investigational product administration))_
- **Number of Participants With Categorical Electrocardiogram (ECG)** _(time frame: Up to Day 4 (3 days after investigational product administration))_

## Locations (2)

- University of Miami Division of Clinical Pharmacology, Miami, Florida, United States
- Orlando Clinical Research Center, Orlando, Florida, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of miami division of clinical pharmacology|miami|florida|united states` — added _(2026-05-12)_
- `locations.orlando clinical research center|orlando|florida|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04091061.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04091061*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*