Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects

NCT04091061 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C2541009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatic Impairment; Healthy Volunteers

Keywords

Non-alcoholic Fatty Liver Disease; Non-alcoholic steatohepatitis

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax)

  Cmax of PF-06865571 was observed directly from data.

  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.

• Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast)

  AUClast of PF-06865571 was determined by linear/log trapezoidal method.

  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.

• Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf)

  AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf).

  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.

Secondary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Up to Day 32 (31 days after investigational product administration)

• Number of Participants With Clinical Laboratory Abnormalities

  Up to Day 4 (3 days after investigational product administration)

• Number of Participants With Categorical Vital Signs Data

  Up to Day 4 (3 days after investigational product administration)

• Number of Participants With Categorical Electrocardiogram (ECG)

  Up to Day 4 (3 days after investigational product administration)

Study Arms (4)

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

Drug: PF-06865571 100 mg

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

Drug: PF-06865571 100 mg

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

Drug: PF-06865571 100 mg

PF-06865571 Healthy Participants

EXPERIMENTAL

This arm includes healthy participants who will receive an oral dose of PF-06865571 100 mg on Day 1

Drug: PF-06865571 100 mg

Interventions

PF-06865571 100 mg DRUG

PF-06865571 in 100 mg oral tablet will be administered on Day 1

PF-06865571 Healthy Participants; PF-06865571 Mild Hepatic Impairment; PF-06865571 Moderate Hepatic Impairment; PF-06865571 Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

University of Miami Division of Clinical Pharmacology

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

ervogastat

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 16, 2019
• Study Start: October 3, 2019
• Primary Completion: April 7, 2020
• Study Completion: April 7, 2020
• Last Updated: April 13, 2021
• Results First Posted: April 13, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)