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

Pfizer1 site in 1 country22 target enrollmentNovember 5, 2019

ConditionsHealthy

InterventionsPF-07081532 Placebo

DrugsPF-07081532 Placebo

Overview

Phase: Phase 1
Intervention: PF-07081532
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 22
Locations: 1
Primary Endpoint: Percentage of participants with vital signs above/below certain threshold
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of PF-07081532 in healthy adult participants.

Registry

clinicaltrials.gov

Start Date

November 5, 2019

End Date

March 17, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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).