Status:
TERMINATED
A Study to Learn How the Study Medicine PF-07899895 Are Tolerated and Act in the Body of Healthy Adults
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purposes of the study are as follows: * To understand how safe and tolerable are different amounts of study medicine (PF-07899895). * To measure the amount of PF-07899895 in blood after the medic...
Eligibility Criteria
Inclusion
- Participants, male or female, must be 18 to 65 years of age, inclusive, at the time of signing the ICD.
- BMI of 16 to 32 kg/m2; and a total body weight\>50 kg (110 lb).
- Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs assessments, oral temperature, 12-lead ECGs, and laboratory tests.
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, bowel resection) or gastrointestinal (GI) transit time (eg, constipation).
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb); positive or indeterminate QuantiFERON test for tuberculosis. Hepatitis B vaccination is allowed.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of undesired reactions to the sun (photosensitivity).
- Recent exposure to live or attenuated vaccines within 28 days of the screening visit.
- 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 PF-07899895 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.
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2025
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT06137729
Start Date
November 17 2023
End Date
October 24 2025
Last Update
November 25 2025
Active Locations (1)
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1
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium, B-1070