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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Healthy Participants

Treatments: Drug: PF-06835919 25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04193436

2019-003480-21 (EudraCT Number)

HEPATIC IMPAIRMENT (Other Identifier)

C1061013

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 4 patient groups

PF-06835919 with severe hepatic impairement

Experimental group

Description:

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

Treatment:

Drug: PF-06835919 25 mg

PF-06835919 with moderate hepatic impairement

Experimental group

Description:

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

Treatment:

Drug: PF-06835919 25 mg

PF-06835919 with mild hepatic impairement

Experimental group

Description:

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

Treatment:

Drug: PF-06835919 25 mg

PF-06835919 without hepatic impairment

Experimental group

Description:

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

Treatment:

Drug: PF-06835919 25 mg