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

Healthy Volunteers Clinical Trial

Official title:

A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF 06865571 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091061
• Other study ID #: C2541009
• Status: Completed
• Phase: Phase 1
• Start date: October 3, 2019
• Est. completion date: April 7, 2020

Study information

• Verified date: March 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 7, 2020
• Est. primary completion date: April 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Hepatic Impairment
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami Division of Clinical Pharmacology	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who receives study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events following start of treatment.	Up to Day 32 (31 days after investigational product administration)
Secondary	Number of Participants With Clinical Laboratory Abnormalities	The following parameters were analyzed for laboratory examination: hematology, clinical chemistry, and urinalysis. The abnormalities with at least 1 participant are presented here.	Up to Day 4 (3 days after investigational product administration)
Secondary	Number of Participants With Categorical Vital Signs Data	Vital signs (systolic and diastolic blood pressure, and pulse rate) were obtained with participants after having sat calmly for at least 5 minutes.	Up to Day 4 (3 days after investigational product administration)
Secondary	Number of Participants With Categorical Electrocardiogram (ECG)	QT interval corrected using Fridericia's formula (QTcF) was obtained with participants. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position.	Up to Day 4 (3 days after investigational product administration)

External Links

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