Status:
COMPLETED
A Study to Learn How Different Amounts of the Study Medicine Called PF-07976016 Are Tolerated and Act in The Body in Healthy Adults
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this clinical trial is to learn if the study medicine (called PF-07976016) is safe and how it goes in and out of the body in healthy people. The study may also explore if PF-07976016 ha...
Eligibility Criteria
Inclusion
- Key
- Male and female participants of non-childbearing potential aged 18 to 65 years, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- A total body weight \>50 kg (110 lb).
- Parts A, B and C only: BMI of 20-33 kg/m2.
- Part D only: BMI of 30-40 kg/m2 and may have well controlled hyperlipidemia or hypertension.
- Key
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, skin or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption.
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
- Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
- Renal impairment as defined by an estimated glomerular filtration rate of \<75 mL/min/1.73 m².
- 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:
- alanine aminotransferase, aspartate aminotransferase, or bilirubin ≥1.05 × upper limit of normal;
- fasting plasma glucose \> 126 mg/dL;
- HbA1c ≥6.0% (Parts A,B and C); HbA1c ≥6.5% (Part D);
- hematuria as defined by ≥1+ heme on urine dipstick;
- albuminuria as defined by urine albumin/creatinine ratio \>30 mg/g.
Key Trial Info
Start Date :
October 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2024
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT06106009
Start Date
October 27 2023
End Date
August 19 2024
Last Update
September 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States, 06511