Study of Single Ascending Doses of PF-07081532 in Healthy Adult Participants
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-07081532 IN HEALTHY ADULT PARTICIPANTS
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
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Bruxelles-capitale, Région DE
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Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
- Brussels Clinical Research Unit
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female (of non-childbearing potential) participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including blood pressure (BP) and pulse rate measurement, temperature, standard 12-lead ECG, telemetry and laboratory tests.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Note that participants enrolling as Japanese must have 4 biological Japanese grandparents who were born in Japan.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis B surface antibody (HBsAb) or hepatitis C antibody (HCVAb).
- 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 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.
- 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 investigational product.
- 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).
- A positive urine drug test at screening or admission.
- Screening supine BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest.
- Screening standard 12-lead single ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline Fridericia-corrected QT [QTcF] interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias).
- 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 (AST) or alanine aminotransferase (ALT) 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; TSH > ULN; HbA1c >= 6.5%.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- Use of tobacco/nicotine containing products more than 5 cigarettes/day.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of the protocol.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Treatment
Participants receiving PF-07081532
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Participants will receive single ascending doses PF-07081532
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Placebo Comparator: Placebo
Participants receiving Placebo
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Participants will receive placebo
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of participants with adverse events
Time Frame: From screening until follow-up call (28-35 days after the last dose of investigational product)
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From screening until follow-up call (28-35 days after the last dose of investigational product)
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|
Percentage of participants with safety laboratory test results above/below certain threshold
Time Frame: Days -1, 2 and 4 of each period and at follow-up visit (7-14 days after the last dose of investigational product)
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Days -1, 2 and 4 of each period and at follow-up visit (7-14 days after the last dose of investigational product)
|
|
Percentage of participants with vital signs above/below certain threshold
Time Frame: Days 1-4 of each period and at follow-up visit (7-14 days after the last dose of investigational product)
|
Days 1-4 of each period and at follow-up visit (7-14 days after the last dose of investigational product)
|
|
Percentage of participants with 12-lead electrocardiogram (ECG) results above/below certain threshold
Time Frame: Days 1-4 of each period and at follow-up visit (7-14 days after the last dose of investigational product)
|
Days 1-4 of each period and at follow-up visit (7-14 days after the last dose of investigational product)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PF-07081532 AUClast
Time Frame: Days 1-4 of each period
|
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration
|
Days 1-4 of each period
|
|
PF-07081532 AUCinf
Time Frame: Days 1-4 of each period
|
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time
|
Days 1-4 of each period
|
|
PF-07081532 Cmax
Time Frame: Days 1-4 of each period
|
Maximum plasma concentration
|
Days 1-4 of each period
|
|
PF-07081532 Tmax
Time Frame: Days 1-4 of each period
|
Time for maximum plasma concentration
|
Days 1-4 of each period
|
|
PF-07081532 t1/2
Time Frame: Days 1-4 of each period
|
Terminal half-life
|
Days 1-4 of each period
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- C3991001
- 2019-003012-30 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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