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

Principal Investigator

Richard Preston

Clinical Trial ID

Institutional Protocol # 20190840
National Clinical Trials Identifier NCT04091061

Clinical Trial Summary


Phase

Phase 1


Funding Agency/Sponsor

Industry


Disease

Other


Enrollment Eligibility

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.

Accepts Healthy Volunteers

Call 3052435930


Contact Information

Study Contact Richard Preston
Phone Number 305-243-2647
Get detailed information on ClinicalTrials.Gov