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STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT

Primary Purpose

Hepatic Impairment, Healthy Volunteers

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-06882961 20MG
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hepatic Impairment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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 38.0 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.

Exclusion Criteria:

  • Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection); NOTE: 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;
  • A positive COVID-19 test at screening;
  • A diagnosis of type 2 diabetes mellitus (T2DM) that is documented by medical history;
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement;
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the 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-06882961;
  • Participants with ANY of the following abnormalities in clinical laboratory tests at Visit 1, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

HbA1c ≥6.5%; FPG ≥126 mg/Dl; eGFR<60 mL/min/1.73m2;

  • A positive urine drug test, for illicit drugs at screening, as assessed by sponsor-identified central laboratory. However, participants in Cohorts 2-4, only, who have been medically prescribed opiates/opioids or benzodiazepines and report the use of these drugs to the investigator at the Screening visit will be allowed to participate; NOTE: repeat urine drug testing is not permitted in this study;
  • At screening or Day -1, a positive breath alcohol test, as assessed using kits provided by sponsor-identified central laboratory, with a single repeat on a separate day permitted to assess eligibility, if needed;
  • 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; 13. 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 this protocol;
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Sites / Locations

  • University of Miami Division of Clinical Pharmacology
  • Orlando Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

PF-06882961 participants without Hepatic Impairment

PF-06882961 participants with mild Hepatic Impairment

PF-06882961 participants with moderate Hepatic Impairment

PF-06882961 participants with severe Hepatic Impairment

Arm Description

This arm includes participants who will receive an oral dose of PF-06882961 20 milligrams (mg) on Day 1

This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1

This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1

This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1

Outcomes

Primary Outcome Measures

Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf)
Area under the plasma concentration time AUC[last])
Maximum plasma concentration (C[max])
Fraction of unbound drug in plasma [fu]

Secondary Outcome Measures

Number of Subjects Reporting Treatment-emergent adverse events (AEs)
Number of Participants With Clinical Laboratory Abnormalities
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Number of Participants With Abnormal Electrocardiogram (ECG)

Full Information

First Posted
October 21, 2020
Last Updated
January 13, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04604496
Brief Title
STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT
Official Title
A Phase 1, Non-randomized, Open-label, Single-dose, Parallel Cohort Study to Compare the Pharmacokinetics of PF-06882961 in Adult Participants With Varying Degrees of Hepatic Impairment Relative to Participants Without Hepatic Impairment.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 30, 2020 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
January 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of PF-06882961

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment, Healthy Volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-06882961 participants without Hepatic Impairment
Arm Type
Experimental
Arm Description
This arm includes participants who will receive an oral dose of PF-06882961 20 milligrams (mg) on Day 1
Arm Title
PF-06882961 participants with mild Hepatic Impairment
Arm Type
Experimental
Arm Description
This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1
Arm Title
PF-06882961 participants with moderate Hepatic Impairment
Arm Type
Experimental
Arm Description
This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1
Arm Title
PF-06882961 participants with severe Hepatic Impairment
Arm Type
Experimental
Arm Description
This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1
Intervention Type
Drug
Intervention Name(s)
PF-06882961 20MG
Intervention Description
PF-06882961 in 20 mg oral tablet will be administered on Day 1
Primary Outcome Measure Information:
Title
Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf)
Time Frame
Hour 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 14 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3
Title
Area under the plasma concentration time AUC[last])
Time Frame
Hour 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 14 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3
Title
Maximum plasma concentration (C[max])
Time Frame
Hour 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 14 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3
Title
Fraction of unbound drug in plasma [fu]
Time Frame
Hour 0 and 4 on Day 1
Secondary Outcome Measure Information:
Title
Number of Subjects Reporting Treatment-emergent adverse events (AEs)
Time Frame
Baseline to Day 30
Title
Number of Participants With Clinical Laboratory Abnormalities
Time Frame
Baseline to Day 3
Title
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time Frame
Baseline to Day 3
Title
Number of Participants With Abnormal Electrocardiogram (ECG)
Time Frame
Baseline to Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 38.0 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. Exclusion Criteria: Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection); NOTE: 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; A positive COVID-19 test at screening; A diagnosis of type 2 diabetes mellitus (T2DM) that is documented by medical history; Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement; Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the 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-06882961; Participants with ANY of the following abnormalities in clinical laboratory tests at Visit 1, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary: HbA1c ≥6.5%; FPG ≥126 mg/Dl; eGFR<60 mL/min/1.73m2; A positive urine drug test, for illicit drugs at screening, as assessed by sponsor-identified central laboratory. However, participants in Cohorts 2-4, only, who have been medically prescribed opiates/opioids or benzodiazepines and report the use of these drugs to the investigator at the Screening visit will be allowed to participate; NOTE: repeat urine drug testing is not permitted in this study; At screening or Day -1, a positive breath alcohol test, as assessed using kits provided by sponsor-identified central laboratory, with a single repeat on a separate day permitted to assess eligibility, if needed; 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; 13. 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 this protocol; Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Miami Division of Clinical Pharmacology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3421014
Description
To obtain contact information for a study center near you, click here.

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STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT

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