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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Healthy Volunteers

Treatments: Drug: PF-06865571 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04091061

C2541009

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

PF-06865571 Moderate Hepatic Impairment

Experimental group

Description:

This arm includes participants with moderate hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1

Treatment:

Drug: PF-06865571 100 mg

PF-06865571 Severe Hepatic Impairment

Experimental group

Description:

This arm includes participants with severe hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1

Treatment:

Drug: PF-06865571 100 mg

PF-06865571 Mild Hepatic Impairment

Experimental group

Description:

This arm includes participants with mild hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1

Treatment:

Drug: PF-06865571 100 mg

PF-06865571 Healthy Participants

Experimental group

Description:

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

Treatment:

Drug: PF-06865571 100 mg