Status:
COMPLETED
A Study to Learn How Different Amounts of the Study Medicine Called PF-06954522 Are Tolerated and Act in the Body in Healthy Adults
Lead Sponsor:
Pfizer
Conditions:
Healthy Participants
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purposes of this study are: * To see how the new medicine (PF-06954522) under study behave. And if there are any important side effects. A side effect is a reaction (expected or unexpected) to a ...
Eligibility Criteria
Inclusion
- 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.
- BMI of 16 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
Exclusion
- 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).
- 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, with the exception of moderate or strong cytochrome P450 3A (CYP3A) inducers or inhibitors which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
- 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 (eGFR) 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 (ALT), aspartate aminotransferase (AST), or bilirubin
- 05 × upper limit of normal (ULN);
- TSH \> ULN;
- HbA1c ≥6.5%;
- Hematuria as defined by ≥1+ heme on urine dipstick;
- Albuminuria as defined by urine albumin/creatinine ratio (UACR) \>30 mg/g.
Key Trial Info
Start Date :
August 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06003777
Start Date
August 30 2023
End Date
February 20 2024
Last Update
June 24 2025
Active Locations (1)
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1
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States, 06511