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

NCT04604496

Last updated date
Study Location
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatic Impairment, Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Hepatic Impairment, Healthy VolunteersSTUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT
NCT04604496
  1. Orlando, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Hepatic Impairment, Healthy VolunteersEffect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
NCT04091061
  1. Miami, Florida
  2. Miami, Florida
  3. Orlando, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT
Official Title  ICMJE 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.
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE
  • Hepatic Impairment
  • Healthy Volunteers
Intervention  ICMJE Drug: PF-06882961 20MG
PF-06882961 in 20 mg oral tablet will be administered on Day 1
Study Arms  ICMJE
  • Experimental: PF-06882961 participants without Hepatic Impairment
    This arm includes participants who will receive an oral dose of PF-06882961 20 milligrams (mg) on Day 1
    Intervention: Drug: PF-06882961 20MG
  • Experimental: PF-06882961 participants with mild Hepatic Impairment
    This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1
    Intervention: Drug: PF-06882961 20MG
  • Experimental: PF-06882961 participants with moderate Hepatic Impairment
    This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1
    Intervention: Drug: PF-06882961 20MG
  • Experimental: PF-06882961 participants with severe Hepatic Impairment
    This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1
    Intervention: Drug: PF-06882961 20MG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 21, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 25, 2022
Estimated Primary Completion Date February 25, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04604496
Other Study ID Numbers  ICMJE C3421014
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP