A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT

NCT04193436 | Completed Phase 1 Results

• 3 other identifiers: C1061013HEPATIC IMPAIRMENT2019-003480-21
• Study Type: interventional
• Target: 23
• Locations: 3 countries
• Sites: 3

Brief Summary

The study is proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919

Conditions

Hepatic Impairment; Healthy Participants

Keywords

Non-alcoholic Fatty Liver Disease; Non-alcoholic steatohepatitis

Outcome Measures

Primary Outcomes (5)

• Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06835919

  AUCinf was defined as area under the plasma concentration time curve from time 0 extrapolated to infinite time.

  Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.

• Maximum Plasma Concentration (Cmax) of PF-06835919

  Cmax was defined as maximum plasma concentration of PF-06835919 and observed directly from data.

  Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.

• Unbound Area Under The Plasma Concentration-Time Curve From Time 0 Extrapolated To Infinite Time (AUCinf,u) of PF-06835919

  AUCinf,u was defined as unbound area under the plasma concentration time curve from time 0 extrapolated to infinite time.

  Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.

• Unbound Maximum Plasma Concentration (Cmax,u) of PF-06835919

  Cmax,u was defined as unbound maximum plasma concentration.

  Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.

• Fraction of Drug Unbound (fu) of PF-06835919

  The fraction of PF-06835919 unbound in plasma (fu) was determined at approximately the expected Tmax in each participant.

  Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.

Secondary Outcomes (3)

• Number of Participants Reporting Treatment-emergent Adverse Events (AEs)

  Baseline (Day 1) up to follow-up (Day 31)

• Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests

  Baseline (Day 1) up to Day 6

• Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)

  Baseline (Day 1) up to Day 6

Study Arms (4)

PF-06835919 with severe hepatic impairement

EXPERIMENTAL

This arm includes participants with severe hepatic impairment who will receive a 25mg oral dose of PF-06835919

Drug: PF-06835919 25 mg

PF-06835919 with moderate hepatic impairement

EXPERIMENTAL

This arm includes participants with moderate hepatic impairment who will receive a 25mg oral dose of PF-06835919

Drug: PF-06835919 25 mg

PF-06835919 with mild hepatic impairement

EXPERIMENTAL

This arm includes participants with mild hepatic impairment who will receive a 25mg oral dose of PF-06835919

Drug: PF-06835919 25 mg

PF-06835919 without hepatic impairment

EXPERIMENTAL

This arm includes participants without hepatic impairment who will receive a 25mg oral dose of PF-06835919

Drug: PF-06835919 25 mg

Interventions

PF-06835919 25 mg DRUG

PF-06835919 in 25 mg oral tablet will be administered on Day 1

PF-06835919 with mild hepatic impairement; PF-06835919 with moderate hepatic impairement; PF-06835919 with severe hepatic impairement; PF-06835919 without 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:

• Male and female participants between the ages of 18 (or the minimum country specific age of consent if \>18) and 70 years, inclusive, at the Screening visit:
• 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; and a total body weight \>50 kg (110 lb).
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

You may not qualify if:

• Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).
• (Participants who have undergone cholecystectomy and/or appendectomy are eligible for this study as long as the surgery occurred more than 6 months prior to Screening)..
• 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 behaviour 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.
• Use of prior/concomitant therapies.
• 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 06835919.
• A positive urine drug test, for illicit drugs, and/or a positive breath alcohol test at Screening. However, participants who have been medially prescribed opiates/opiods or benzodiazepines and report the use of these drugs to the investigator at the screening visit will be allowed to participate.
• 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.
• History of sensitivity to heparin or heparin induced thrombocytopenia, only if heparin is used to flush intravenous catheters used during serial blood collections.
• Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of the protocol.
• 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 (3)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Pharmaceutical Research Associates CZ, s.r.o.

Prague, 170 00, Czechia

Location

Summit Clinical Research, s.r.o.,

Bratislava, 83101, Slovakia

Location

Related Links

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

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

PF-06835919

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: November 11, 2019
• First Posted: December 10, 2019
• Study Start: January 21, 2020
• Primary Completion: July 9, 2021
• Study Completion: July 9, 2021
• Last Updated: February 16, 2024
• Results First Posted: February 16, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); SL (1); CZ (1)