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A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Formulation A (PF-07081532 20 mg plus 60 mg)
Formulation B (PF-07081532 80 mg)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring PF-07081532

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male and female participants must be at least 18 years of age, inclusive, at the time of signing the ICD Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECGs Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures A total body weight >50 kg (110 lb) and BMI of 25.0 to <34.9 kg/m2, inclusive, at the screening visit Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and protocol Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection) History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2, or pancreatitis, 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 prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention In females, current use of hormone replacement therapy or oral/injectable contraceptives containing ethinyl estradiol Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of study intervention used in this study. Investigational products which are strong CYP3A inducers or time-dependent inhibitors are prohibited within 14 days plus 5 half-lives or 30 days (whichever is longer) prior to the dose of study intervention Known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF-07081532 or known intolerance to a GLP-1R agonist A positive urine drug test Using a properly sized and calibrated BP cuff, screening supine BP ≥140 mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate- age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third- degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the uncorrected QT interval is >450 ms, this interval should be rate-corrected using the Fridericia method only and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: Aspartate aminotransferase or alanine aminotransferase level ≥1.25 × upper limit of normal (ULN); Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN; HbA1c ≥6.5%; Fasting blood glucose ≥126 mg/dL (7 mmol/L); Calcitonin > ULN; eGFR <60 mL/min/1.73 m2 as calculated by the CKD-EPI equation.

Sites / Locations

  • New Haven Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Formulation A (Reference) followed by Formulation B (Test)

Formulation B (Test) followed by Formulation A (Reference)

Arm Description

Outcomes

Primary Outcome Measures

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations A and B
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations A and B
Maximum Observed Plasma Concentration (Cmax) for Formulations A and B

Secondary Outcome Measures

Number of Participants Reporting Treatment-Emergent Adverse Events
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
December 13, 2022
Last Updated
March 21, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05677867
Brief Title
A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese
Official Title
A PHASE 1, OPEN-LABEL, 2-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF 2 DIFFERENT FORMULATIONS OF PF-07081532 ADMINISTERED ORALLY TO ADULT PARTICIPANTS WHO ARE OVERWEIGHT OR OBESE
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
March 14, 2023 (Actual)
Study Completion Date
March 14, 2023 (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 purpose of this study is to compare the amount of PF-07081532 in blood after taking two different forms of PF-07081532. This study is seeking participants who are at least 18 years of age and are overweight and/or obese. All study participants will receive a total of 2 single doses of this study medication in either form. Form A consists of a PF-07081532 20 mg immediate release tablet and a PF-07081532 60 mg immediate release tablet. Form B consists of a PF-07081532 80 mg immediate release tablet. Each single dose will be separated by a minimum of 6 days. The amount of PF-07081532 in the blood for 4 days after taking each single dose will be compared between the two different formulations of PF-07081532. The total time that participants will take part in this study is about 70 days. The first visit is a screening visit to ensure that participants are appropriately qualified for the study. This will occur up to 28 days before the first single dose. Participants will be admitted into the clinic one day prior to the first single dose and will remain in the clinic for a total of 11 days. The study team will phone the participants 28 to 35 days after the last dose of study medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
PF-07081532

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
PF-07081532 80 mg will be provided in 2 different oral formulations (A and B). Formulation A will be administered as a PF-07081532 20 mg immediate release tablet and a 60 mg immediate release tablet. Formulation B will be administered as a PF-07081532 80 mg immediate release tablet. The overall design is a randomized, open-label, single dose, 2-period, 2-sequence, crossover study.
Masking
None (Open Label)
Masking Description
(open label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Formulation A (Reference) followed by Formulation B (Test)
Arm Type
Experimental
Arm Title
Formulation B (Test) followed by Formulation A (Reference)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Formulation A (PF-07081532 20 mg plus 60 mg)
Intervention Description
Formulation A: administered as a 20 mg immediate release tablet and a 60 mg immediate release tablet
Intervention Type
Drug
Intervention Name(s)
Formulation B (PF-07081532 80 mg)
Intervention Description
Formulation B: administered as a 80 mg immediate release tablet
Primary Outcome Measure Information:
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations A and B
Time Frame
Day 1 (hour) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 (hour) 24 and 36, Day 3 (hour) 48, Day 4 (hour) 72 and Day 5 (hour) 96
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations A and B
Time Frame
Day 1 (hour) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 (hour) 24 and 36, Day 3 (hour) 48, Day 4 (hour) 72 and Day 5 (hour) 96
Title
Maximum Observed Plasma Concentration (Cmax) for Formulations A and B
Time Frame
Day 1 (hour) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 (hour) 24 and 36, Day 3 (hour) 48, Day 4 (hour) 72 and Day 5 (hour) 96
Secondary Outcome Measure Information:
Title
Number of Participants Reporting Treatment-Emergent Adverse Events
Time Frame
Baseline through End of Study (Day 35)
Title
Number of Participants with Clinical Laboratory Abnormalities
Time Frame
Baseline, Day -1 (one day before dosing in Period 1), and Day 11 (at the end of Period 2)
Title
Number of Participants with Clinically Significant Change from Baseline in Vital Signs
Time Frame
Baseline, Day 1 (on 1st day of Period 1), Day 7 (on 1st day of Period 2) and Day 11 (at the end of Period 2)
Title
Number of Participants with Abnormal Electrocardiogram (ECG)
Time Frame
Baseline, Day 1 (on 1st day of Period 1), Day 7 (on 1st day of Period 2) and Day 11 (at the end of Period 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female participants must be at least 18 years of age, inclusive, at the time of signing the ICD Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECGs Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures A total body weight >50 kg (110 lb) and BMI of 25.0 to <34.9 kg/m2, inclusive, at the screening visit Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and protocol Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection) History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2, or pancreatitis, 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 prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention In females, current use of hormone replacement therapy or oral/injectable contraceptives containing ethinyl estradiol Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of study intervention used in this study. Investigational products which are strong CYP3A inducers or time-dependent inhibitors are prohibited within 14 days plus 5 half-lives or 30 days (whichever is longer) prior to the dose of study intervention Known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF-07081532 or known intolerance to a GLP-1R agonist A positive urine drug test Using a properly sized and calibrated BP cuff, screening supine BP ≥140 mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate- age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third- degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the uncorrected QT interval is >450 ms, this interval should be rate-corrected using the Fridericia method only and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: Aspartate aminotransferase or alanine aminotransferase level ≥1.25 × upper limit of normal (ULN); Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN; HbA1c ≥6.5%; Fasting blood glucose ≥126 mg/dL (7 mmol/L); Calcitonin > ULN; eGFR <60 mL/min/1.73 m2 as calculated by the CKD-EPI equation.
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
New Haven Clinical Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
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=C3991010
Description
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A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese

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