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

• ClinicalTrials.gov Identifier: NCT04604496
• Recruitment Status: Completed
• First Posted: October 27, 2020
• Last Update Posted: January 18, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

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

Condition or disease	Intervention/treatment	Phase
Hepatic Impairment; Healthy Volunteers	Drug: PF-06882961 20MG	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• 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.
• Actual Study Start Date: December 30, 2020
• Actual Primary Completion Date: January 10, 2022
• Actual Study Completion Date: January 10, 2022

Arms and Interventions

Arm	Intervention/treatment
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	Drug: PF-06882961 20MG; PF-06882961 in 20 mg oral tablet will be administered on Day 1
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	Drug: PF-06882961 20MG; PF-06882961 in 20 mg oral tablet will be administered on Day 1
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	Drug: PF-06882961 20MG; PF-06882961 in 20 mg oral tablet will be administered on Day 1
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	Drug: PF-06882961 20MG; PF-06882961 in 20 mg oral tablet will be administered on Day 1

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. Fraction of unbound drug in plasma [fu] [ Time Frame: Hour 0 and 4 on Day 1 ]

Secondary Outcome Measures :

1. Number of Subjects Reporting Treatment-emergent adverse events (AEs) [ Time Frame: Baseline to Day 30 ]
2. Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: Baseline to Day 3 ]
3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline to Day 3 ]
4. Number of Participants With Abnormal Electrocardiogram (ECG) [ Time Frame: Baseline to Day 3 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

University of Miami Division of Clinical Pharmacology

Miami, Florida, United States, 33136

Orlando Clinical Research Center

Orlando, Florida, United States, 32809

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04604496
• Other Study ID Numbers: C3421014
• First Posted: October 27, 2020
• Last Update Posted: January 18, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• 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/data_requests.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Liver Diseases; Digestive System Diseases